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This online, on-demand virtual symposium brings together renowned experts in dermatology to discuss newer treatments for patients with psoriasis.

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Patients with this rare and severe skin disorder may soon have a new therapeutic option.

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Dustin Portela, DO, a board-certified dermatologist and dermatologic surgeon at Treasure Valley Dermatology in Boise, Idaho.

Dustin Portela, DO, a board-certified dermatologist and dermatologic surgeon at Treasure Valley Dermatology in Boise, Idaho, discusses Jori Skincare for hormonal acne with Josh Zeichner, MD, medical advisor of Jori Skincare and director of cosmetic & clinical research in dermatology at Mount Sinai Hospital in New York City.

Opinions expressed are that of Portela and do not express the views or opinions of Dermatology Times®.

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In this week’s Pointers with Dr Portela, the 208SkinDoc interviews Josh Zeichner, MD, and discusses Jori Skincare. 

Pointers with Dr Portela: Interview with Josh Zeichner, MD 

The most valuable asset for nearly every dermatologist is their ability to practice their profession, as the future income stream from this asset is significant and quantifiable. To protect this asset for themselves and for others dependent on them, dermatologists rely on disability and life insurance as fundamental “asset protectors.” Young dermatologists should secure these tools early in their careers, and established physicians should regularly review existing insurance policies to ensure they are maintaining necessary levels of protection.

In part 1 of this 2-part article, we will focus on the basics physicians need to know about disability insurance, and we will cover life insurance in part 2.

The disability of the family breadwinner can be more financially devastating to a family than premature death. With many disability cases, the medical care alone can cost hundreds of dollars per day, increasing expenses significantly while income is reduced or eliminated.

EMPLOYER-PROVIDED COVERAGE OFTEN INADEQUATE

If you are an employee of a university, hospital, or large dermatology practice, your employer may provide long-term disability coverage. Group disability, however, often limits either the term of the coverage or the amount of benefits paid. For instance, benefits may last only a few years or benefit payments may represent only a small part of your annual compensation. Since this is most commonly an employer-paid benefit, the money received during your disability will be income taxable to you. Additionally, employer or group disability coverage can be terminated at any time and for any reason, leaving you without coverage. 

GETTING THE BEST INSURANCE COVERAGE FOR THE MONEY: INDIVIDUAL DISABILITY 

Because many physicians do not have access to group disability insurance and group coverage can prove lacking if the need arises, all dermatologists should consider individual disability insurance to protect the value of their future incomes. When evaluating options for an individual disability insurance policy, it is important to work with a reputable and experienced insurance adviser, who can help you with answers to the following questions:

Most policies are capped at a benefit amount that equals 60% of income. You must ask yourself how much money your family would need if you became disabled. 

2. WHAT IS THE WAITING PERIOD (ELIMINATION PERIOD)? 

This is the period of time that you must be disabled before the insurance company will pay disability benefits. The longer the waiting period before benefits begin, the lower your premium will be. Essentially, the waiting period serves as a deductible relative to time—you cover your expenses for the waiting period, then the insurance company steps in from that point forward.

It’s a good idea to get a benefit period of coverage that lasts until Social Security benefit payments begin, sometime between aged 62 and 70 years. Unless you are still too young to qualify for Social Security, a policy that provides lifetime benefits, at costly premiums, is generally not worth the added expense.

4. WHAT IS THE DEFINITION OF DISABILITY? 

Definitions vary from insurance company to insurance company, and even from policy to policy within the same company. The definition of disability used for a policy is of the utmost importance. The main categories are own-occupation, any-occupation, and loss of income. The own-occupation policies, which pay a benefit if you can’t continue your own occupation (even if you can and do work in another occupation after the disability), are the most comprehensive. 

5. DOES THE POLICY OFFER PARTIAL BENEFITS? 

If you can work only part-time instead of your previous full-time hours, will you receive benefits? Unless your policy states that you are entitled to partial benefits, you won’t receive anything unless you are totally unable to work. Also, are extended partial benefits paid if you go back to work and suffer a reduction in income because you cannot keep up the same rigorous schedule you had before you became disabled? 

6. IS BUSINESS OVERHEAD EXPENSE COVERED? 

If you are a practice owner, whether you have $10,000 or $20,000 of monthly disability benefits, you likely don’t have enough to cover your lost income plus the costs of running the practice. 

7. IS IT NONCANCELABLE OR GUARANTEED RENEWABLE? 

The difference between these terms is very important. If a policy is noncancelable, you will pay a fixed premium throughout the contract term and your premium will not go up for the term of the contract. If it is guaranteed renewable, the policy cannot be canceled but your premiums could go up. Ideally you want a policy that is both noncancel-able and guaranteed renewable. 

8. HOW FINANCIALLY STABLE IS THE INSURANCE COMPANY? 

Before buying a policy, check the financial soundness of your insurer. 

The value of a dermatologist’s future income is a valuable asset that needs protection, both for the physician and for dependents who rely on that income. Dermatologists rely on disability and life insurance as fundamental protectors of this asset and should purchase these policies early in their careers. Here, in part 1 of this 2-part article, we focused on what doctors need to know about disability insurance. We will cover life insurance in part 2. 

Jason O’Dell is a financial consultant, insurance specialist, and partner in the wealth management firm OJM Group (www.ojmgroup.com) in Cincinnati, Ohio. Michael Lewellen is partner and director of financial planning at OJM Group.

OJM Group, LLC. (“OJM”) is an SEC registered investment adviser with its principal place of practice in the State of Ohio. SEC registration does not constitute an endorsement of OJM by the SEC nor does it indicate that OJM has attained a particular level of skill or ability. OJM and its representatives are in compliance with the current notice filing and registration requirements imposed upon registered investment advisers by those states in which OJM maintains clients. OJM may only transact practice in those states in which it is registered or qualifies for an exemption or exclusion from registration requirements. For information pertaining to the registration status of OJM, please contact OJM or refer to the Investment Adviser Public Disclosure web site www.adviserinfo.sec.gov.

For additional information about OJM, including fees and services, send for our disclosure brochure as set forth on Form ADV using the contact information herein. Please read the disclosure statement carefully before you invest or send money. 

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Articles

Jason M. O'Dell, MS, CWM, and Michael Lewellen, CFP, discuss what young dermatologists need to know about insurance basics to protect themselves. 

Protecting a Physician’s Most Valuable Asset: Insurance Basics for Young Dermatologists

Acne is an extremely common skin disease and while particularly prevalent in adolescents, it can persist into adulthood as well. Most dermatology providers are very familiar with treating acne, as approximately 15% of the US population has suffered from acne and, by some estimates, nearly 9 out of 10 adolescents have also suffered from this condition. Julie Harper, MD, a board-certified dermatologist in private practice in Birmingham, Alabama, a founding director and past president of the American Acne and Rosacea Society, gave a presentation on acne treatment updates at the Maui Derm NP+PA Summer 2022 conference.

Before discussing treatments, Harper took time to highlight the goals of acne treatment and she shared her CLEAR acronym for effective treatment. The 3 most important goals of acne treatment are achieving meaningful improvements in lesion count, preventing sequalae, and improving quality of life. The CLEAR acronym can help accomplish this by reminding providers how to best counsel patients on effective treatment—C: communicate expectations, L: listen to customize treatment, E: treat early, A: treat aggressively, R; don’t resist isotretinoin. This was followed by a brief discussion on the role of topical therapy in acne treatment. Topical therapy is considered first-line treatment in most mild to moderate patients and it can be used as monotherapy or as combination therapy. However, topical antibiotics should rarely be used as monotherapy. There is also some utility for topical therapy in the treatment of acne sequelae. 

Harper began her focused update on treatments with topical retinoids, which work by binding to the retinoic acid receptor, which modulates genes associated with acne etiology. Specifically, topical retinoids normalize follicular epithelial hyperkeratinization and are anti-inflammatory in nature. There have been 4 generations of FDA-approved topical retinoids, with the most recent approval for trifarotene 0.005% cream in 2019. This novel topical therapy is the first new retinoid molecule the FDA has approved in over 20 years and was studied on facial and truncal acne. In phase 3 clinical trials, trifarotene achieved a 42% IGA/PGA success rate at week 12 and a 65% absolute reduction in inflammatory lesions for both face and trunk.

 “Topical retinoids remain a cornerstone of acne treatment. I am grateful that we have seen innovation in this space. We have a whole new retinoid molecule, trifarotene, created to specifically and precisely target the retinoic acid receptors (RAR ) receptor,” Harper said. 

Harper followed her discussion of trifarotene with another retinoid, tazarotene lotion 0.045%. This medication was FDA approved in 2019 for daily use in patients 9 years and older with moderate-to-severe acne. In a phase 2 study, tazarotene lotion performed better than tazarotene 0.1% cream in percent change in mean inflammatory and non-inflammatory lesions at week 12.

 The novel vehicle, polymeric emulsion technology, allows for a lower percentage of active ingredients, which improves the tolerability of tazarotene, traditionally an irritating agent. Before moving on to oral agents, Harper mentioned 2 other important topical therapies. First was E-tretinoin 0.1%/E-BPO 3% cream, which can be stabilized together through microencapsulation technology. This technology also allows for improved tolerability of the medication. Next, clascoterone was highlighted and the unique mechanism of action was displayed. Clascoterone is a topical anti-androgen that binds to the androgen receptor and has limited systemic activity.

 In 1 clinical trial, IGA treatment success for clascoterone was 16.1% vs 7% for the vehicle. This medication is the first topical antiandrogen for acne and is appropriate for use in both male and female patients. “We all have a tendency to think of our oral antibiotics in the management of acne as being the heavy lifter once they are added to a treatment regimen, but in fact the topicals are the unsung heroes,” Harper said. “While there are no head-to-head studies, clinical trials consistently show more acne patients achieve clear or almost clear with topical agents than with oral antibiotics.” 

Harper also discussed oral therapy, which she said is equally as important as topical therapy. Oral therapy is recommended for moderate-to-severe acne that does not respond to other treatments or for inflammatory acne that is nonresponsive to topical antibiotics. Sarecycline, the newest oral antibiotic therapy, offers a narrow spectrum of therapy because it has a minimal effect against gram-negative bacilli. The advantage of this narrow spectrum may be a reduced tendency to disrupt normal gut flora.

 Sarecycline is taken once a day with or without food, and adverse events, while uncommon, include nausea and vaginal yeast infections. Its activity against C acnes is equivalent to that of doxycycline and minocycline. 

Harper highlighted spironolactone oral therapy, which is not FDA approved for acne treatment but remains a popular option. She reviewed some high-yield pearls when using spironolactone. There is no need to check potassium in healthy women (between aged 18 and 45 years).

 There is no evidence of an increased risk of breast cancer, despite its FDA black box warning stating that “spironolactone has been shown to be a tumorigen in chronic toxicity study in rats.”

 Spironolactone takes 2 to 3 months to achieve optimal efficacy. An ideal way to use this medication is in combination with other acne treatments (topical therapies or oral antibiotics) and it even can be used in combination with oral contraceptives.

 Practically, dosage should be between 25 and 200 mg, but Harper prefers a maximum dose of 100 mg. A higher dose of spironolactone will lead to a high rate of side effects. 

Harper ended her talk with isotretinoin, one of the most commonly used medications for the treatment of acne. She noted that the goal of isotretinoin therapy is complete clearance with 1 course of treatment while minimizing adverse effects and risks. An appropriate end point often varies by provider but a study by Tan et al found that the traditional end point dose of 120 to 150 mg/kg appears to vary with severity.

 Optimal end point dosing of isotretinoin has the goal of preventing relapse. Relapse can be defined in different ways, such as deterioration in acne requiring systemic therapy and those who require retreatment with oral isotretinoin.

 Relapses still occur in 20% to 30% of cases and less than 120 mg/kg is considered a cumulative dose that is too low. Patient characteristics that make relapse more common include younger age, male gender, severe presentation, females with polycystic ovary syndrome, and patients who present with a large number of comedones. 

Harper reviewed laboratory monitoring with isotretinoin therapy. A study by Zane et al found that the greatest perturbation in laboratory abnormalities on isotretinoin were in triglycerides and total cholesterol.

 As such, the FDA package insert states that “blood lipid determination should be performed before isotretinoin is given and then at intervals until lipid response is established, which is usually about 4 weeks.” A meta-analysis on laboratory evaluation of isotretinoin found that while lab values demonstrated a change from baseline, none of them were considered high risk changes.

The authors recommended performing lipid and hepatic panels at baseline and 2 months after therapy, with repeat labs dictated by medical history. 

Harper wrapped up her presentation with a discussion on the risk of depression and suicide in patients on isotretinoin therapy, a traditionally contentious topic. A systematic review on the topic conducted by Huang et al in 

The Journal of The American Academy of Dermatology

 analyzed 31 studies and found that only 1 had evidence to show that isotretinoin significantly increased the risk of depression.

 The authors concluded that although individual susceptibility to depression cannot be ruled out, isotretinoin can be safely used without increasing the risk of depression. Another medical expenditure panel survey study, which utilized questionnaires like the Kessler 6-Item Psychological Distress Scale, found that patients on isotretinoin had fewer depressive symptoms than those on oral antibiotics and had less psychological distress.

It is exciting to see new innovation in the treatment of acne and review the critical data on traditional therapies. Given the frequency with which this condition is seen in the dermatologist’s office, the management of acne is always an important topic to stay updated on. 

Harper is a consultant and/or speaker for Almirall, Cassiopea Pharmaceuticals, Cutera, EPI Health, Galderma, Journey Medical Corporation, L’Oréal, Ortho Pharmaceutical, Sol-Gel, SUN Dermatology, and VYNE Therapeutics. She is also an investigator for Almirall. For full list of references, see dermatology-times.com

1. Tan J, Thiboutot D, Popp G, et al. Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne. J Am Acad Dermatol. 2019;80(6):1691-1699. doi:10.1016/j.jaad.2019.02.044

2. Tanghetti EA, Kircik LH, Green LJ, et al. A phase 2, multicenter, double-blind, randomized, vehicle-controlled clinical study to compare the safety and efficacy of a novel tazarotene 0.045% lotion and tazarotene 0.1% cream in the treatment of moderate-to-severe acne vulgaris. J Drugs Dermatol. 2019;18(6):542.

3. Hebert A, Thiboutot D, Stein Gold L, et al. Efficacy and Safety of Topical Clascoterone Cream, 1%, for Treatment in Patients With Facial Acne: Two Phase 3 Randomized Clinical Trials. JAMA Dermatol. 2020;156(6):621- 630. doi:10.10 01/jamadermatol.2020.0465

4. Zhanel G, Critchley I, Lin LY, Alvandi N. Micro-biological profile of sarecycline, a novel targeted spectrum tetracycline for the treatment of acne vulgaris. Antimicrob Agents Chemther. 2019;63(1):e01297-18. doi:10.1128/A AC.01297-18

5. Plovanich M, Weng QY, Mostaghimi A. Low usefulness of potassium monitoring among healthy young women taking spironolactone for acne. JAMA Dermatology. 2015;151(9):941-944. doi:10.1001/jamadermatol.2015.34

6. Wei C, Bovonratwet P, Gu A, Moawad G, Silver-berg JI, Friedman AJ. Spironolactone use does not increase the risk of female breast cancer recurrence: a retrospective analysis. J Am Acad Dermatol. 2020;83(4):1021-1027. doi:10.1016/ j.jaad.2020.05.081

7. Garg V, Choi JK, James WD, Barbieri JS. Long-term use of spironolactone for acne in women: a case series of 403 patients. J Am Acad Dermatol. 2021;84(5):1348-1355. doi:10.1016/j.jaad.2020.12.071

8. Tan J, Knezevic S, Boyal S, Waterman B, Janik T. Evaluation of evidence for acne remission with oral isotretinoin cumulative dosing of 120-150 mg/kg. J Cutan Med Surg. 2016;20(1):13-20. doi:10.1177/1203475415595776

9. Strauss JS, Rapini RP, Shalita AR, et al. Isotretinoin therapy for acne: results of a multicenter dose-response study. J Am Acad Dermatol. 1984;10(3):490 -496. doi:10.1016/s0190 -9622(84)80100 - 0

10. Layton AM, Knaggs H, Taylor J, Cunliffe WJ. Isotretinoin for acne vulgaris--10 years later: a safe and successful treatment. Br J Dermatol. 1993;129(3):292-296. d o i :10 .1111/ j .13 6 5 - 213 3 .19 9 3 . t b118 4 9. x

11. Zane LT, Leyden WA, Marqueling AL, Manos MM. A population-based analysis of laboratory abnormalities during isotretinoin therapy for acne vulgaris. Arch Dermatol. 20 06;142(8):1016 -1022. doi:10.10 01/a r c h d e r m .142.8.1016

12. Huang YC, Cheng YC. Isotretinoin treatment for acne and risk of depression: a systematic review and meta-analysis. J Am Acad Dermatol. 2017;76(6):1068 -1076.e9. doi:10.1016/ j.jaad.2016.12.028

13. Hekmatjah J, Chat VS, Sierro TJ, Read C, Kassardjian AA, Armstrong AW. Differences in depression and distress between acne patients on isotretinoin vs oral antibiotics. J Drugs Dermatol. 2021;20(2):172-177. doi:10.36849/JDD.5559

14. J. Harper, H. Baldwin, D. Eichenfield. Acne and Rosacea Update 2022. Presented at Maui Derm NP+PA Summer 2022; June 23-25, 2022; Colorado Springs, Colorado.

Julie Harper, MD, a board-certified dermatologist in private practice in Birmingham, Alabama, a founding director and past president of the American Acne and Rosacea Society, gave a presentation on acne treatment updates at the Maui Derm NP+PA Summer 2022 conference. 

Acne Updates: Pearls on Treating Acne from a Recent Maui Derm Conference

In late July 2022, Edgewell Personal Care Company announced the voluntary recall of Banana Boat Hair & Scalp Sunscreen Spray SPF 30 to consumers.

After an internal investigation, some samples of the sunscreen were found to have contained trace levels of benzene. Benzene is not an ingredient found in Banana Boat products, but the investigation found unexpected levels of benzene in the propellant of the aerosol spray cans.

No other batches of Banana Boat Hair & Scalp, before or after the 3 batch codes, are part of the voluntary recall. Additionally, no other Banana Boat products contain benzene and are safe for consumers to use.

"It is not surprising to me that yet another product has been recalled due to contamination with the well-known human carcinogen benzene - in this case some Banana Boat hair and scalp sunscreen sprays," said Christopher Bunick, MD, PhD, associate professor of dermatology at the Yale Department of Dermatology in New Haven, Connecticut. "Although not unique to sprays, sprays have tended to have the most problems with benzene contamination, including in sunscreens, anti-perspirants, and anti-fungal over-the-counter products." 

Benzene is an organic chemical classified as a human carcinogen that is formed both naturally and man-made.

 Volcanoes and forest fires are natural sources of benzene. Crude oil, gasoline, cigarette smoke, glue, and certain paints all contain varying levels of benzene. According to the FDA, “Exposure to benzene can occur by inhalation, orally, and through the skin and it potentially can result in cancers including leukemia and blood cancer of the bone marrow and blood disorders which can be life threatening. To date, Edgewell has not received any adverse events related to this recall.”

Humans come into contact with trace amounts of benzene daily in outdoor and indoor environments. Daily exposure to benzene due to the Banana Boat sunscreen is not expected to cause adverse events.

"I commend Edgewell Personal Care Company, the maker of Banana Boat sunscreens, for performing and reporting their quality control findings. This transparency and commitment to correcting the benzene contamination problem in the manufacturing process of personal care products is necessary to improve their safety and protect the health of the public, especially given that robust research into the long-term effects of benzene exposure through personal care products is still lacking at this time," said Bunick. 

Edgewell has notified all retailers to remove any remaining products from their shelves. Banana Boat is also offering reimbursements to consumers who purchased a product with one of the lot codes in the table above. Any adverse events related to the use of the product should be reported to the FDA’s MedWatch Adverse Event Reporting program via mail, fax, or online.

Edgewell personal care issues voluntary nationwide recall of banana boat hair & scalp sunscreen due to the presence of benzene. U.S. Food and Drug Administration. Published July 29, 2022. Accessed August 9, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/edgewell-personal-care-issues-voluntary-nationwide-recall-banana-boat-hair-scalp-sunscreen-due

Facts about benzene. Centers for Disease Control and Prevention Published May 15, 2019. Accessed August 9, 2022. https://emergency.cdc.gov/agent/benzene/basics/facts.asp

Edgewell Personal Care Company issued a voluntary national recall of 3 collections of Banana Boat Hair & Scalp Sunscreen due to the presence of benzene. 

Banana Boat Hair & Scalp Sunscreen Spray SPF 30 Recalled 

With that, I want to give us some cases to review. Maybe we can break down some of the nuts and bolts with that. I’ll give you 3 different cases. I’ll read them to you, and we can review how we would take care of them and what our impression is.

The first case is a patient who’s Fitzpatrick skin type 1 to 2. She is 4 years old was previously diagnosed with moderate atopic dermatitis. She was and referred to the dermatologist with red, dry, itchy patches on the arms, which is what we’d see with a first-time patient, especially from a nondermatologist referral. She’s been treated with nonpharmacological agents, such as emollients and moisturizers, given multiple topical steroids, probably in generic vehicles. Since 6 months old, she has been on steroids cyclically. Her parents have noted that the rashes and itching keep progressively getting worse each year. After 6 months of being diagnosed and now being 4 years old, things are starting to roll downhill.

When talking with dermatologists, parents keep mentioning disturbed sleep, missing preschool because of poor sleep, and having to take time off work for all that. The parents don’t sleep either. They dress her in long-sleeve clothes even on hot days, doing more to avoid peers and the other little kids from seeing what’s going on. The family is trying to hide the scratch marks on her arms. You can get the essence that the disease is progressing. There are definitely a lot of psychosocial issues involved with both the child and the family. Trying to manage things from behind has been the approach. Omar, I’ll start with you, what’s your initial thought? Obviously this patient has a lighter skin type, itching is either in proportion or even out of proportion of the rash, and then everything else that goes with the nonpharmacological management aside from steroids. What’s your impression of what’s going on so far?

It sounds like this young child has a more moderate atopic dermatitis, with the itch obviously playing a large role in that. Her body surface area is not dramatic because she’s so small. But we know that the symptoms also can contribute to what we classify as a more moderate patient. It sounds as if they’re doing a good job with their emollients and skin care. We don’t have to have a crazy discussion around washcloths, loofahs, things like that, and using Irish Spring for instance. Talking about our gentle cleansers and things like that—an overall barrier discussion.

Beyond that, we see how much this is affecting her life. We have a very suitable option in dupilumab that has now been approved for 6 months of age. We know that these psychosocial issues that you discussed will affect her growth, her ability to learn, and everything else—her ability to sleep, her family’s ability to cohesively live together. If we can improve her itching, her scratching, and her eczema with something like a once-a-month injection with dupilumab, that can positively influence the entire family dynamic.

Yes, but it’s also important to get at the cycle early—the amount of surface area but also the amount of itch, as you just described. Those are significant drivers to that. Angela, we talked about age with the new indication of dupilumab, the location, the amount of surface area. What other adjuncts besidesdupilumab would go along with it. How would you incorporate dupilumab in that discussion? They probably have been used to treating from the top down, and now we’re adding something a little more systemic.

I don’t know what your clinical practice has been. I love dupilumab, but I often find that everybody has 1 or 2 little resistant patches, particularly patients who are so severe. You always want to have something topical for people to use, so definitely in these circumstances. I love crisaborole. It’s a great nonsteroidal option. Also, we need to continue the religious barrier protection and emollients. Even for my patients on dupilumab, I always tell them you should treat your skin the way you were treating it before. Let’s be compulsive about the reapplication of the emollient and using the gentle cleansers. As Omar said, don’t use the Irish Spring. Don’t think you can all of a sudden start using all this fancy fragrant stuff. Let’s keep it simple. Apply emollients religiously 2 to 3 times a day, and then you always could use a medium-potency steroid for those breakthrough areas. As much as I love the medication, I find that almost everybody has that little breakthrough. Sometimes it’s hard to know if they’re not moisturizing as religiously now that their skin is so much better and maybe they just need to put on more emollients, but I like to give people options that they can use in those cases.

 is my favorite term. You hit it right on the head. There are going to be stubborn areas, there’s going to be as such. Even days where the kid goes swimming or something else, that’s the time to add another layer of moisturizer, for example. I try to make sure too to put steroids back into context because. If they’ve been dependent on steroids, and now we’re switching gears and go into biologics, we can still use steroids effectively and not be reliant on them. It puts everything back into getting rid of some of the phobias and misconceptions.

As we talked about clinical research, in 18-year-olds, every 1 of those drugs—crisaborole, ruxolitinib, upadacitinib, dupilumab, tralokinumab—have had contingencies for rescue therapy and for adding on. Then the KRONOS trial for dupilumab and a couple of others were done with topical steroids. The Measure Up trial with upadacitinib and a couple of others also did that. Putting it into context where we can use steroids effectively but not be dependent on them will get more of the parents onboard.

The other part of the equation is proving that the safety has been approved by the FDA for 6 months. That gives us a lot of leverage in getting these drugs covered. You guys hit on some good points.

A 4-year-old girl previously diagnosed with moderate AD was referred to a dermatologist with red, dry, itchy patches on her arms. She has been treated with non-pharmacological products (emollients and moisturizers) and multiple topical corticosteroids since her diagnosis at 6 months of age. Her parents noted that the rashes and itching have been getting worse for past one year.

When talking with dermatologists, her parents mentioned disturbed sleep causing her to routinely miss preschool. Parent admitted to sometimes dressing her in long sleeve clothes even on hot days to avoid her peers and family from seeing scratches on her arms.

Experts discuss the case of a 4-year-old girl with lighter skin and treatment options for a young child.

AD Patient Case: FST I

Joshua Zeichner, MD, an associate professor of dermatology and director of cosmetic and clinical research in the Department of Dermatology at Mount Sinai Hospital in New York, New York; and Mona Gohara, MD, a dermatologist at Dermatology Physicians of Connecticut in Hamden, Connecticut, and president of the Women’s Dermatologic Society, discussed their experiences and preferences in treating acne with non-prescription drugs. 

To determine the efficacy of over the counter (OTC) acne drugs, Zeichner and Gohara first discussed a 2019 study

 that analyzed adherence issues of topical treatments for acne vulgaris. Patients from the study used retinoids, antibacterial treatments, benzoyl peroxide, retinoid antibacterial treatments, and formulas containing resorcinol salicylic acid. Nearly half of the patients discontinued topical therapy before their scheduled time, citing unresponsiveness and adverse effects as primary reasons. Gohara began the discussion by saying she is not surprised by the number of patients who discontinue topical therapies, noting that many of her patients have told her their topical therapies did not work. 

Gohara stressed that retinoids and benzoyl peroxide are the gold standards for acne treatment in dermatology, but only when used correctly. While these OTC drugs are not prescription strength, they can still be irritating to the skin when used in large quantities or mixed with other irritating agents. Gohara explained that she gives her patients a handout that shows how to use OTC drugs, such as retinoids, correctly. She said dermatologists should take time to talk with their patients about how to use the product, as well as realistic expectations. 

Zeichner echoed these experiences, saying he gives his patients specific guidance on how much product to use, how often, and what other OTC products to combine with topical therapies for the best results. He noted that a pea-sized amount of product is typically all you need; a cherry tomato-sized amount is too much. Overall, Zeichner sees that many patients want results too quickly; most patients will not see results until approximately week 12. Another way Zeichner tries to understand his patients’ expectations is by asking them to walk him through their skin care regimen. This helps Zeichner know what they already use and what kind of results they desire. 

“I always say to patients when they come back, ‘First of all, how do you feel about your skin?’ I like to hear what they have to say before I make a comment and I’ll say to them, ‘Take me through your regimen.’ I always ask open-ended questions. We have to be nonjudgmental, educate our patients, and set realistic expectations,” said Zeichner. 

Most importantly, both experts stressed that it’s crucial not to be judgmental. Asking patients questions will benefit both the dermatologist and the patient to come up with an agreed-upon acne treatment plan. Gohara also mentioned a few tricks, such as mixing a light moisturizing cream with a retinoid or benzoyl peroxide to cut the irritation and not using retinoids as a spot treatment. 

Zeichner and Gohara discussed non-prescription cleansers and moisturizers for acne-prone skin. In a 2020 study

, 4 name-brand, lipid-free cleansers were studied and compared. Gohara began by pointing out the beneficial ingredients of each product. She stressed that hydrating ingredients are always beneficial, no matter the type of skin. Both Zeichner and Gohara mentioned the importance of a healthy skin barrier. A strong skin barrier is not always the first thought in acne management, but it’s the skin’s line of defense. Ceramides in cleansers help the outermost layer of skin by keeping irritants out and keeping water locked in. Skin barrier dysfunction is related to blockages in the pores that contribute to acne. 

“Lipid-free cleansers are primarily composed of water and glycerin; those are the 2 primary ingredients, which are obviously very highly rated,” said Gohara. “We can see that primarily, these cleansers will have very low rates of irritation on the skin and can help the skin barrier, which is what we were talking about before. Lipid-free cleansers can mitigate the irritation that patients may be getting from retinoids and benzoyl peroxides.” 

The main goal of moisturizers is to repair significant defects in the skin barrier and assist with acne treatment. Gohara said dermatologists and patients must be deliberate when selecting a moisturizer. She considers structural components of the skin and whether the moisturizer is depositing ceramides into the epidermal barrier. Additionally, moisturizers can have other ingredients such as sunscreen that are also beneficial to the skin. 

Both Zeichner and Gohara noted 3 top ingredients for hydrating skin in moisturizers:

•occlusives: create a blanket to prevent transepidermal water loss (TEWL)

•humectants: suck water up from the dermis and epidermis

•emollient: a layer between epidermal cells to stop TEWL 

Moisturizers should have more ingredients than just a humectant, as humectants are great at grabbing water, not trapping it. Hyaluronic acid is an example of one that should not be used alone and should be layered with a moisturizer. 

To end another informative webinar series, Zeichner and Gohara concluded that OTC skin care products such as cleansers and moisturizers should never compromise the integrity of the skin barrier. Products should include ingredients that will protect, soften, and hydrate the skin, not irritate it. Discussing OTC products and individualized treatment plans with acne-prone patients will result in better adherence rates as well as achievable expectations. 

Zeichner J, Gohara M. The role of non-prescription products in the management of acne. Between the Lines webinar. July 15, 2022. Accessed July 20, 2022.

In a webinar from the Between the Lines series, 2 dermatology experts discussed challenges in adherence with acne treatments, updates on available moisturizers and cleansers, factors that influence the selection of moisturizers and cleansers for acne-prone patients, and data from 2 studies.  

The Role of Non-Prescription Products in the Management of Acne

VYNE Therapeutics, a biopharmaceutical company that develops therapies for immuno-inflammatory conditions, announced the phase 2a section of the phase 1b/2a clinical trial monitoring FMX114 gel for the treatment of mild-to-moderate atopic dermatitis (AD) did not meet its primary endpoints.

Study VY2021-01 did not meet its endpoint of improving symptoms and severity of AD based on the absolute and percent change relative to the baseline in the Atopic Dermatitis Severity Index (ADSI). According to David Domzalski, CEO of Vyne Therapeutics, the company will closely review the data to complete their analysis and rediscuss their pipeline.

Just over 20 patients were enrolled in the phase 2a study, which was designed to monitor 4 weeks of FMX114 treatment in patients with mild-to-moderate AD. To qualify for enrollment, patients had to show proof of 2 comparable target AD lesions for treatment. Target lesions were selected randomly and treated twice per day with FMX114 or vehicle.

The efficacy of phase 2a was concluded based on the absolute and percent change related to baseline in the ADSI scoring after week 4. The mean ADSI scores for FMX114 and vehicle treated lesions were 6.6 and 6.9 at baseline. The mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle treated lesions at week 4 (P=.228, OC, ITT).

The phase 2a section of VY2021-01 was a randomized, double-blind clinical trial designed to compare the safety and efficacy of FMX114 gel and a vehicle gel. Initially, phase 2a was intended to enroll up to 25 patients, with each patient acting as their own control. Both the phase 1b and 2a study required patients to have 2 comparable target AD lesions. After phase 2a, patients would have been eligible to participate in a 2-week open label treatment phase with the active drug applied to both lesions.

VYNE Therapeutics announces results from its phase 2a trial of FMX114 for the treatment of mild-to-moderate atopic dermatitis – VYNE Therapeutics. Accessed August 10, 2022. https://vynetherapeutics.com/press-releases/vyne-therapeutics-announces-results-from-its-phase-2a-trial-of-fmx114-for-the-treatment-of-mild-to-moderate-atopic-dermatitis/ 

VYNE Therapeutics Inc. announced the results of study VY2021-01.  

Phase 2a FMX114 Study for AD Did Not Meet Primary Endpoints

Atopic dermatitis (AD) is one of the most common inflammatory skin diseases. It is characterized as a chronic, type II inflammatory skin disease that exhibits the following prominent features: xerosis, pruritis and ill-defined erythematous plaques. There were limited treatment options until recently, with an increased understanding of the immunological nature of this disease. There is now a rich pipeline of new therapeutics for AD, especially systemic therapies. Eric Simpson, MD, MCR, and professor of dermatology at Oregon Health & Science University, delivered a broad presentation at Maui Derm NP+PA Summer 2022 on systemic therapies of AD, focusing on appropriate use criteria. “This is an exciting time for offering safe and effective novel therapies to patients with moderate-to-severe AD who are inadequately controlled with topical therapy,” Simpson said.

The presentation began with an overview of the current treatment armamentarium for AD, which includes topical medications for mild to moderate disease and systemic treatments for moderate-to-severe disease. As disease severity increases, clinicians should consider moving from topical to systemic medications. However, this decision is sometimes complicated and may differ from 1 clinician to another. Guidelines were presented by the International Eczema Council, which suggested that systemic therapy should be employed if aggressive topical therapy is not achieving control of the disease.

 However, before moving straight to systemic therapy, clinicians must ensure that adequate education is delivered and any infectious comorbidities (which could make mild AD seem more like a moderate-to-severe presentation) are addressed. Also, phototherapy should be considered before oral or injectable therapy and systemic therapy should be considered early in the patient’s treatment course if their disease is having a large impact on their quality of life. 

While the International Eczema Guidelines provide some guidance on the appropriate use of systemic AD treatments, some clinicians feel they are vague, and 1 clinician’s definition of “aggressive topical therapy” may differ from another’s definition. The Atopic Dermatitis Control Tool (ADCT) mitigates this issue by using an extensively validated, 6-item questionnaire to assess the severity of a patient’s AD.

 This instrument boasts multiple domains, including sleep, intense itching, emotions, and daily activities. The ADCT is free to download and use and is great for serially tracking a patient’s response in one’s practice. Validation studies performed on this measure concluded that this holistic tool displays good-to-excellent content validity, construct validity, internal consistency, reliability, and discriminating ability.

 “I encourage all dermatology providers to recognize a patient with inadequate disease control prompting a discussion of new options and to not just refill topical or oral steroids,” said Simpson. 

Before moving on to systemic treatments for AD, Simpson reminded the audience that this disease could have many comorbidities, including dyspigmentation, infection, and hand/facial involvement.

 These issues are especially prevalent in skin-of-color patients and should be considered when selecting an appropriate AD therapy. He warned that overuse of steroids should be considered a topical therapy failure and that clinicians must remember that treating with topical steroids is not without adverse effects. These include perioral dermatitis, atrophy, acne, and steroid withdrawal.

 Some inexperienced clinicians may aggressively use high-potency topical steroids in severe cases of AD, which could lead to further complications. This is another reason why tools such as the ADCT are useful in clinical practice. 

Systemic treatments were reviewed in depth during the next part of the presentation. “There are now 2 biologics targeting type 2 inflammation and 2 oral JAK inhibitors that provide your patients with AD hope for a life free of itch and eczema,” Simpson said. He reminded the audience that traditional immunosuppressants (such as methotrexate or cyclosporine) and Narrowband Ultraviolet B Phototherapy are also options for systemic treatment of AD, in addition to biologics and JAK inhibitors.

 Traditional immunosuppressants (ie, cyclosporine, methotrexate, mycophenolate, azathioprine) still have utility in today’s therapeutic landscape. The biggest factor is cost, as traditional therapies are much cheaper and easier to access than the newer JAK inhibitors and biologics. Cyclosporine at high doses remains 1 of the most efficacious systemic AD therapies.

 One of the biggest disadvantages is that these therapies are used off-label. Also, rigorous lab monitoring requirements and solid organ toxicities make these agents difficult to use on a regular basis. Specifically, cyclosporine can cause renal toxicity, and methotrexate can cause liver and blood toxicity. Strict monitoring of creatinine is necessary while using cyclosporine and sometimes a test dose of methotrexate is given to patients to ensure there is no precipitous drop in blood cell counts. 

There are numerous factors to consider when prescribing a systemic therapy for AD. While severity of disease and associated comorbidities are important, clinicians need to also consider issues such as access, coverage, age, risk aversion, and previous therapeutic history. Simpson stressed the importance of shared decision-making when discussing systemic therapy. This is critical, as some systemic therapies for AD carry black box warnings that patients may ask about. In short, shared decision-making comprises 3 domains—team talk, option talk, decision talk—and encourages active listening with careful deliberation.

 An example of option talk is the following statement: “Let’s compare the possible options for you on systemic therapies of AD.” Simpson used cyclosporine, methotrexate, and dupilumab as examples of option talk highlighting unique adverse events such as hypertension, liver toxicity, and conjunctivitis, respectively. 

While biologic agents such as dupilumab and tralokinumab do not have some of these more serious adverse events, they are not good options for needle-phobic patients or for patients who want a short-term solution. These therapies are very versatile and can be used for any patient without adequate control on topical therapy. Simpson reviewed the clinical trial data for dupilumab, an interleukin-4 receptor-α antago-nist, and specifically highlighted its recent FDA approval for patients as young as 6 years. The proportion of patients 18 years or older who were clear or almost clear at week 16 averaged 37% in SOLO 1 [NCT02277743] and SOLO 2 [NCT02277769] phase III clinical trials.

Dupilumab is also FDA-approved for the treatment of asthma and chronic rhinosinusitis with nasal polyps. Data show that treatment with dupilumab improves skin barrier and decreases cutaneous inflammation and staph aureus colonization in AD involved skin.

 Key updates for this medication were highlighted, including documented 4-year, long-term safety data, improvement in efficacy over time in non-responders, and documented safety in elderly patients and in patients with HIV or hepatitis B. 

After discussing dupilumab, Simpson reviewed the data for tralokinumab, the newest biologic agent FDA-approved for AD. Traloki-numab is an anti-interleukin-13 blocking agent which has a slower onset than dupilumab but is longer lasting. As with dupilumab, conjunctivitis is a common side effect but it occurs less frequently compared with dupilumab therapy. In the ECZTRA [NCT03363854] phase III clinical trials, tralokinumab achieved an EASI 75 of about 90% at week 32.

 Drug survival studies indicate that this high response rate is maintained over a 2-year period. Data were presented showing that treatment with tralokinumab leads to a shift towards a non-lesional skin phenotype over a 2-year period. 

Simpson ended his presentation13 by discussing JAK inhibitors, the newest class of systemic medications for the treatment of AD. The JAK/STAT signaling pathway was reviewed along with the advantages that JAK inhibitors offer for AD treatment. Not only do JAK inhibitors offer flexible dosing regimens with an oral route of administration, but they can also provide relief of symptoms as early as 1 to 2 weeks after treatment initiation. Simpson reviewed the 2 FDA-approved therapies, abrocitinib and upadacitinib. These are both JAK 1 inhibitors but upadacitinib is approved down to aged 12 years. Unfortunately, these agents have black box warnings so they should not be used in patients with a history of malignancy, severe infections, thrombotic events, severe renal/hepatic disease, or significant cardiovascular disease. He ended the presentation by offering a few practical considerations for JAK inhibitor use in the clinical setting. Drug-to-drug interactions should be checked before prescribing, patients should be up to date on vaccinations, and labs should be drawn at baseline and every 1 to 3 months thereafter. While more research is needed, it is not advised to use these medications during pregnancy or breastfeeding. For any provider who treats even just a few AD patients per week, this talk was certainly not to be missed given the excellent and practical tips that were presented. 

Simpson is a consultant for Arena Pharmaceuticals, BenevolentAI, BiomX Ltd, Bluefin Biomedicine, Boehringer Ingelheim, Collective Acumen LLC, Coronado Biosciences, Evidera, Forte Biosciences Inc, Janssen Pharmaceuticals, Ortho Galderma, Laboratoires Pierre Fabre, Roivant Sciences, SPARC India, Trevi Therapeutics, and Bausch Health. 

He has also received grants from AbbVie, Amgen, Aslan Pharmaceuticals, Celgene Corporation, Dermia LLC, Dermavant Sciences, Eli Lilly and Company, Galderma, Incyte, Kymab Ltd, Kyowa, Leo Pharma, Merck & Co, Novartis, Pfizer Inc, and Regeneron Pharmaceuticals, Inc. 

1. Simpson EL, Bruin-Weller M, Flohr C, et al. When does atopic dermatitis war-rant systemic therapy? Recommendations from an expert panel of the International Eczema Council. J Am Acad Dermatol. 2017;77(4):623-633. doi:10.1016/ j.jaad.2017.06.042

2. Simpson E, Eckert L, Gadkari A, et al. Validation of the Atopic Dermatitis Control Tool (ADCT) using a longitudinal survey of biologic-treated patients with atopic dermatitis. BMC Dermatol. 2019 ;19 (1):15. doi :10.118 6/s12895- 019 -0095-3

3. Pariser DM, Simpson EL, Gadkari A, et al. Evaluating patient-perceived control of atopic dermatitis: design, validation, and scoring of the Atopic Dermatitis Control Tool (ADCT). Curr Med Res Opin. 2020;36(3):367-376. doi:10.1080/03007995. 2019.169 9516

4. Kaufman BP, Guttman-Yassky E, Alexis AF. Atopic dermatitis in diverse racial and ethnic groups-variations in epidemiology, genetics, clinical presentation and treat-ment. Exp Dermatol. 2018 ;27(4):340-357.doi :10 .1111/ exd .13514

5. Hajar T, Leshem YA, Hanifin JM, et al. A systematic review of topical corticosteroid withdrawal (“steroid addiction”) in patients with atopic dermatitis and other dermatoses. J Am Acad Dermatol. 2015;72(3):541-549.e2. doi:10.1016/j.jaad.2014.11.024

6. Sidbury R, Tom WL, Bergman JN, et al. Guidelines of care for the management of atopic dermatitis: section 4. Prevention of disease flares and use of adjunctive therapies and approaches. J Am Acad Dermatol. 2014;71(6):1218 -1233. doi:10.1016/ j.jaad.2014.08.038

7. Drucker AM, Ellis AG, Bohdanowicz M, et al. Systemic immunomodulatory treatments for patients with atopic dermatitis: a systematic review and network meta-analysis. JAMA Dermatol. 2020;156(6):659- 667. doi:10.10 01/jamadermatol.2020.0796

8. Elwyn G, Frosch D, Thomson R, et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012;27(10):1361-1367. doi:10.10 07/s11606-012-2077-6

9. Simpson EL, Bieber T, Guttman-Yassky E, et al. Two phase 3 trials of dupilumab versus placebo in atopic dermatitis. N Engl J Med. 2016;375(24):2335-2348. doi:10.1056/ NEJMoa1610 020

10. Callewaert C, Nakatsuji T, Knight R, et al. IL-4Rα blockade by dupilumab decreases staphylococcus aureus colonization and increases microbial diversity in atopic dermatitis. J Invest Dermatol. 2020;140(1):191-202. e7. doi :10 .1016 / j .jid.2019.05.024

11. Guttman-Yassky E, Bissonnette R, Ungar B, et al. Dupilumab progressively improves systemic and cutaneous abnormalities in patients with atopic dermatitis. J Allergy Clin Immunol. 2019 ;143(1):155-172. doi :10 .1016 / j. j a c i .2018.08.022

12. Silverberg JI, Toth D, Bieber T, et al. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2021;184(3):450-463.doi :10 .1111/ b jd.19573

13. Simpson E, Eichenfield, L. Atopic dermatitis update 2022. Presented at: Maui Derm NP+PA Summer 2022; June 23-25, 2022, Colorado Springs, Colorado.

Eric Simpson, MD, MCR, and professor of dermatology at Oregon Health & Science University presents exciting new systemic therapy treatment options for atopic dermatitis.

When to Progress to Systemic Therapy

Zoe Diana Draelos, M.D., is a consulting professor of dermatology, Duke University School of Medicine, Durham, N.C. She is investigator, Dermatology Consulting Services, High Point, N.C., and a Dermatology Times Editorial Advisor and co-medical editor.

Cracked heels are a common debilitating problem in mature adults. Due to the trauma of walking, which can increase with advancing age and orthopedic issues, the skin on the heels can thicken. In addition, skin desquamation does not proceed with its youthful fervor in maturity. Although seemingly innocuous, cracked heels can become a major medical issue in patients with diabetes as the crack can extend into viable skin and provide an entry for infection. The pain of cracked heels can also interfere with ambulation. I have an instruction sheet I give my patients to assist with cracked heels because I get asked so frequently about this problem. I thought I would share my time-saving instructions with you.

Q: What is the best way to cut and groom thickened toenails?

Thickened toenails can be very challenging to cut. The same procedure described above can also be used to soften thickened toenails by hydrating the keratin. Hydrated keratin is more ductile and softer, making it much easier to cut with scissors or toenail clippers. The same instructions as above can be used, except after step 9 add the following: Use scissors or toe-nail clipper to trim your softened nails on both feet. Then resume with step 10, instructing the patient to apply petroleum jelly and wear thin socks to bed. The lukewarm water penetrates the nail plate better when the dishwashing detergent is added. The surfactant aids in water penetration by removing any oily debris from the surface and slightly denaturing the keratin protein, thus opening up water-binding sites. This allows extra hydration to occur, which softens the keratin and decreases the cutting force. This is important so the nail does not crack.

Q: What is unique about products designed for diabetic feet?

A number of companies have launched products specifically for diabetic skin, including foot products. This segmentation of the moisturizer market has led to products for eczema, itchy skin, rough skin, bumpy skin (keratosis pilaris), and diabetic skin. This is a way of creating more sales through expanded product offerings with descriptions that encourage sales by speaking to certain populations that may not be traditional users of moisturizer. An individual may purchase the moisturizer because “it is just for me and my unique skin condition.” The question remains whether these segmented moisturizers contain different ingredients from those in nonsegmented moisturizers. The answer is “maybe.” Diabetic foot products tend to have a higher viscosity and more moisturizing ingredients that occlude the skin surface to encourage hydration, such as petrolatum, shea butter, and dimethicone. Although these ingredients are indicative of the extra dry skin found in diabetic feet, they are not unique to diabetic foot products. 

This procedure is best done in the evening just before going to bed:

Fill a plastic dishpan with about 2 inches of lukewarm water to completely submerge your heels.

Add 2 drops of dish soap and swirl the solution a few times with your hand.

Put a towel close by for drying your feet.

Place the dishpan on the floor and put your feet in for 15 minutes.

After 15 minutes, take your right foot out and set it on your left leg. Leave your left foot in for continued soaking.

Use your fingernails to scrape away the dead skin on your right foot. Do not use scissors, sharp files, or grinders. Only scrape away what can be easily removed. Put your right foot back in the dishpan.

Take your left foot out of the dishpan and set it on your right leg. Leave your right foot in for continued soaking.

Use your fingernails to scrape away the dead skin on your left foot. Again, do not use scissors, sharp files, or grinders. Only scrape away what can be easily removed. Put your left foot back in the dishpan.

Repeat scraping the dead skin from both feet until no more can be easily removed. Usually 2 to 3 repetitions are sufficient, depending on the amount of dead skin.

Apply petroleum jelly to your feet and put on thin socks.

Retire for the evening and sleep in the socks.

Remove the socks in the morning and go about your regular daily grooming.

Repeat the soaking procedure nightly until the cracked calloused skin has been removed.

Repeat the procedure as often as necessary to prevent calloused skin from returning.

In this month's Cosmetic Conundrums column, Zoe Diana Draelos, MD, participates in a Q&A about dry and cracked feet. 

Focusing on Feet 

The US Food and Drug Administration (FDA) issued 3 warning letters to Amazon, Ariella Naturals, and Justified Laboratories for adding unapproved mole and skin tag removal products into interstate commerce.

The unapproved drugs violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Currently, the FDA has not approved any OTC drugs for the removal of moles and skin tags.

Amazon, Ariella Naturals, and Justified Laboratories received warning letters from the FDA. 

The Role of Non-Prescription Products in the Management of Acne

Phase 2a FMX114 Study for AD Did Not Meet Primary Endpoints

When to Progress to Systemic Therapy

Focusing on Feet

FDA Issues 3 Warning Letters to Companies Selling Unapproved Drugs for Mole and Skin Tag Removal

Perspectives on Generalized Pustular Psoriasis