In this podcast, Hilary Baldwin, MD, FAAD, and Jeffrey Fromowitz, MD, FAAD, discuss the burden of rosacea, management tips, available treatments, antibiotic stewardship, and more.

Managing Papulopustular Rosacea

Learn more about what treatments are on the rise for plaque psoriasis, the latest management advice and what trends are shaping the future of the disease. 

The changing treatment landscape of plaque psoriasis

Videos

Klint Peebles, MD, FAAD, co-chair of the AAD LGBTQ/GSM Expert Resource Group, tips and resources for maintaining your mental health as a gender and sexual minority. 

Tips for Maintaining Mental Health as a Gender and Sexual Minority 

Biologic therapy in dermatology has transformed the treatment of various systemic and cutaneous diseases. However, immunosuppression and immunomodulatory therapies can be challenging in patients with chronic infectious diseases, and clinicians must practice caution when contemplating treatment in this patient population, said Kieron Leslie, MD, in a presentation at the American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX) in April.

“Particularly in patients with chronic infectious diseases such as viral hepatitis, tuberculosis (TB), HIV, and now COVID-19 infections, finding the appropriate treatment can be difficult,” said Leslie, dermatologist in the Dermatology Clinic at Mount Zion and professor of dermatology at the University of California, San Francisco School of Medicine, both located in San Francisco, California. 

“As systemic immunosuppressive therapies are precluded in this patient population, physicians need to be clear on what they can prescribe and what to avoid.”

Managing immunosuppressive therapy in patients and determining how best to oversee the vaccination of those patients against COVID-19 is a key issue for dermatologists. According to Leslie, the current evidence in the dermatological and rheumatological literature indicates that, in general, immunosuppressives are not a significant risk factor for COVID-19 infection. However, high-dose steroid use does appear to have an increased infection risk of the virus.

The AAD recently released guidelines regarding the appropriate administration of immunosuppressives in the COVID-19 pandemic era.

 This guidance recommends that immunosuppressive agents be continued in patients who have not tested positive for COVID-19 or exhibited signs or symptoms of COVID-19 but should be discontinued in patients who are infected with COVID-19. The agents can be restarted when a patient has recovered from the virus. Also, clinicians should consider the risks, benefits, and balances with comorbidities such as obesity, diabetes, and hypertension in patients who may require the start of new medications.

“The AAD guidelines regarding the restart of medications, however, are not clearly defined, as they could mean restart 7 to 14 days after symptoms subside or after polymerase chain reaction [PCR] testing becomes negative,” Leslie said. As such, the decision has been left up to the clinician’s discretion and judgment.”

Clinicians have several immunosuppressive therapies to choose from in the dermatologic armamentarium. Options include high-dose corticosteroids, etanercept, guselkumab (Tremfya; Janssen Biotech) and methotrexate (MTX). Leslie advised avoiding high-dose corticosteroids when possible. No other agents have been implicated yet in an increased risk of COVID-19 infection.

The AAD has not issued guidelines regarding how to vaccinate patients on immunosuppression, however, the American College of Rheumatology (ACR) has. It shares many of the same medications used in dermatology.

Based on the ACR guidelines, Leslie noted that there are no modifications to therapy or vaccination timing with regard to immunosuppressives, apart from MTX and JAK inhibitors such as tofacitinib.

Patients taking certain JAK inhibitors should be placed on a drug holiday 1 week after each vaccination dose. For rituximab, the vaccine series should be initiated approximately 4 weeks prior to the next scheduled rituximab cycle. The administration of infliximab does not require modifications to the timing of COVID-19 vaccination.

Individuals with HIV are more susceptible to a whole host of inflammatory skin diseases, particularly psoriasis and eczema, and often have extremely severe disease, especially when their HIV is not controlled well. According to Leslie, antiretroviral therapy is effective for these patients and can quickly improve their psoriasis symptoms.

“Psoriasis is very common in [individuals] living with HIV, almost double the incidence of patients without HIV, and is particularly severe when the CD4+ count is low,” Leslie said. “The first line therapy here is antiretrovirals together with concomitant skin-directed therapies including topical corticosteroids, phototherapy, and retinoids.”

There is no evidence on whether immunosuppressive agents can be used safely in HIV-positive patients who fail these treatment measures because all patients with HIV are typically excluded from these clinical studies, Leslie said. National Psoriasis Foundation guidelines issued in 2010 suggest optimizing antiretroviral therapy, using topical medications, and, as a second line, using systemic acitretin.

“This approach does not work for everyone and...there have been many case reports of various agents being used in [HIV-positive] patients with psoriasis, including cyclosporine, MTX, apremilast, and IL-17 blockers such as secukinumab and guselkumab, essentially most of the agents that are FDA approved,” Leslie said.

The greatest body of evidence from case series and case reports are tumor necrosis factor α blockers, which, according to Leslie, likely reflect the clinicians’ familiarity with these agents, followed by the IL-12 and IL-23 blockers, such as ustekinumab, and the IL-17 blockers.

“It’s fair to say that the biologics are preferred to conventional disease modifying drugs such as cyclosporine or MTX, as these do seem to [lead to] a higher rate of infection,” Leslie said. 

Various types of eczema and prurigo also are very common in individuals with HIV infection. Recently, there have been a number of case series using dupilumab in patients with HIV without any reported adverse events. Leslie noted that the safety profile reported thus far with dupilumab is encouraging.

When contemplating immunosuppression treatment in dermatology patients with HIV, Leslie suggested a 4-step approach:

1. Try to optimize antiretroviral therapy by suppressing the patient’s viral load and raising CD4 count.

2. Consider other nonimmunosuppressive alternatives such as phototherapy, other topicals, and apremilast (Otezla; Amgen). 

3. Consult with the patient’s HIV/ID provider if immunosuppressants are deemed necessary.

4. Monitor patients carefully once treatment is initiated, including viral load and CD4 count. 

According to the National Psoriasis Foundation, Leslie said, acitretin is the only medication that can be safely used in HIV-positive patients, as the retinoids are considered a second-line agent in this patient population.

Leslie also sees broader issues evolving. Chronic infectious diseases such as viral hepatitis, TB, HIV, and COVID-19 disproportionally affect minority populations and individuals immigrating to the United States who may not have health coverage. Bringing appropriate therapy to these patient subsets can be challenging and should be addressed, Leslie said.

Leslie reported no relevant or financial disclosures.

1. Leslie K. Danger and defense in the age of biologics. American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX); April 23-25, 2021; virtual. Accessed April 30, 2021.

2. Guidance on the use of immunosuppressive agents. American Academy of Dermatology. Updated October 15, 2020. Accessed May 4, 2020. https://www.aad.org/member/practice/coronavirus/clinical-guidance/biologics

3. COVID-19 vaccine clinical guidance summary for patients with rheumatic and musculoskeletal diseases. American College of Rheumatology. Updated March 4, 2021. Accessed May 6, 2021. 

https://www.rheumatology.org/Portals/0/Files/COVID-19-Vaccine-Clinical-Guidance-Rheumatic-Diseases-Summary.pdf

4. Menon K, Van Voorhees AS, Bebo BF Jr, et al. Psoriasis in patients with HIV infection: from the medical board of the National Psoriasis Foundation. J Am Acad Dermatol. 2010;62(2):291-299. doi:10.1016/j.jaad.2009.03.047

Articles

Biologic therapy has proven very useful in treating an increasing number of dermatologic diseases and conditions. However, caution is warranted for patients with chronic infectious diseases. 

Dangers, Benefits of Biologics Must Be Carefully Weighed

Dermatologists are well aware that skin pigmentation affects cutaneous vitamin D synthesis, making vitamin D deficiency more common among people with skin of color. Now the COVID-19 pandemic increases the need to give due consideration to that connection, according to Pearl E. Grimes, MD.

Soon after COVID-19 case numbers started to rapidly rise worldwide, researchers began to hypothesize and investigate risk factors for infection and worse outcomes. Results showing associations with vitamin D deficiency appeared early and continued to grow.

In an article published in July 2020, Grimes and colleagues were the first to suggest that low vitamin D status could be among the variables explaining the higher burden of COVID-19 among people of color.

Noting the need for further research to corroborate their hypothesis, the authors called on physicians to be aware of the higher prevalence of vitamin D deficiency in patients with skin of color and address the issue as a possible way to resolve the disparities in COVID-19 risks affecting minority populations. 

Nine months later, information in an accumulating body of literature strengthens this call to action, said Grimes, director of The Grimes Center for Medical and Aesthetic Dermatology and founder and director of Vitiligo and Pigmentation Institute of Southern California in Los Angeles. “As we move this agenda forward, we need a cohesive effort where all physicians are talking to their patients about the importance of having a healthy level of vitamin D,” she told 

. “Physicians must continue to emphasize the importance of vaccination, frequent handwashing, wearing masks, and social distancing as strategies for protecting against COVID-19 infection. However, the available evidence indicates that having a healthy level of vitamin D is also important for decreasing the risk. Furthermore, data also support the idea that for individuals who develop COVID-19, having a healthy vitamin D level will increase the likelihood of having a better outcome.”

Reviewing the evidence on the associations between vitamin D status and COVID-19 infection and outcomes, Grimes cited a meta-analysis published online in March 2021. Aggregating literature published through November 26, 2020, the authors identified 39 studies meeting the criteria for inclusion in their systematic review.

Results of the meta-analysis showed linked vitamin D deficiency with increased risks of COVID-19, as well as higher composite severity and increased mortality from the disease. The findings were replicated in another meta-analysis published later in the month that reviewed 43 published studies using a literature search cutoff date of January 31, 2021.

The relationship between vitamin D status and COVID-19 infection as it specifically applies to race and ethnicity was the topic of another study conducted at the University of Chicago, with results published online in March 2020.

 The findings further corroborate research showing an association between vitamin D deficiency (<20 ng/mL) and COVID-19 infection.

However, the study was primarily designed to investigate potential racial differences in COVID-19 risk among persons with vitamin D levels of 30 to less than 40 ng/mL, which some experts consider sufficient. 

The investigators found that among Black people, the risk of testing positive for COVID-19 rose significantly, by 2.64-fold, among those with a vitamin D level of 30 to less than 40 ng/mL compared with those who had a level of at least 40 ng/mL. COVID-19 positivity rates among White people did not differ significantly when comparing the subgroup with a vitamin D level of 30 to less than 40 ng/mL and their counterparts with a higher level. The authors concluded that their findings support the idea that vitamin D supplementation could lead to COVID-19 infection rates. 

As reviewed in the numerous published papers, including the article by Grimes, an association between vitamin D status and COVID-19 risk and outcomes is grounded on solid biologic plausibility. First, vitamin D signaling plays a key role in maintaining healthy innate and adaptive immune responses. In addition, and of particular relevance, vitamin D has been shown to mediate the induction of key antimicrobial peptides in the respiratory epithelium and inhibit production of proinflammatory cytokines that are upregulated in the COVID-19 cytokine storm.

“Two other recent meta-analyses published in the years preceding the COVID-19 pandemic linked vitamin D with risk of respiratory tract infections,” Grimes observed. “One found an increased risk of community-acquired pneumonia in persons with vitamin D levels less than 20 ng/mL, and another reported vitamin D supplementation protected against acute respiratory tract infection.”

As she aims to raise health care providers’ awareness that vitamin D status may be an important modifiable risk factor for COVID-19, especially in patients with skin of color, Grimes also is taking the message directly to the public, encouraging patients to have a dialogue with their physicians about vitamin D. To accomplish this, Grimes collaborated with producer and director Felicia D. Henderson to produce an informational YouTube video, The Colors of COVID: Saving Lives and the Benefits of D-Z-C.

The 13-minute film features Henry W. Lim, MD, chairman and C.S. Livingood chair of the Department of Dermatology at Henry Ford Health System in Detroit, Michigan, alongside other medical and nutrition experts (Jonathan Sackier, MB; R. Swamy Venuturupalli, MD; and Lee Bell, BCHN) and Black celebrity activists (Tyler Perry, Angela Bassett, Nicole Ari Parker, and Jenifer Lewis). It concludes with this appeal: “Please consult your health care professional to ascertain what supplementation is right for you.”

Hopefully, concern about contracting COVID-19 will lessen in the future. However, the need to recognize and address low vitamin D status in patients with skin of color will continue to be a priority, according to Grimes. “Clinicians need to be aware of evidence showing that vitamin D insufficiency is a risk factor for many serious diseases, including diabetes, hypertension, cardiovascular disease, autoimmune diseases, and various cancers that occur at disproportionately high rates in skin of color populations,” she said. 

Grimes acknowledged that there are conflicting data about the benefit of vitamin D supplementation for reducing disease risks and improving health outcomes. In particular, skeptics cite results from the Vitamin D and Omega-3 Trial (VITAL; NCT01169259), a nationwide, randomized, placebo-controlled trial of healthy adults that found supplementation with vitamin D3 2000 IU per day did not lower the risk of invasive cancers or major cardiovascular events.

 “However, when you dive into the details of the published article, you see that the study [results] found a possible benefit for decreasing the incidence of cancer among Black participants,” she said.

While awaiting results from prospective studies that may help define the benefits of different dosing strategies, physicians should encourage patients with skin of color to take a daily vitamin D supplement, Grimes said. “The Institute of Medicine–recommended dietary allowance for vitamin D is 600 to 800 IU per day for adults, and the recommendation is based on bone health. Given the very high incidence of vitamin D deficiency in African Americans not taking supplements, higher doses are needed to achieve healthy levels.

“I think physicians can feel comfortable recommending to their adult patients that they take 1000 to 2000 IU of a vitamin D3 supplement each day,” she continued. “According to the National Academy of Medicine, most people can safely take up to 4000 IU per day without significant risk of hypercalcemia. I encourage health care providers to read the literature to develop their own knowledge base on this topic.” 

1. Grimes PE, Elbuluk N, Alexis AF. The relevance of vitamin D supplementation for people of color in the era of COVID-19. J Drugs Dermatol. 2020;19(7):782-783. doi:10.36849/JDD.2021.5414

2. Kazemi A, Mohammadi V, Aghababaee SK, Golzarand M, Clark CCT, Babajafari S. Association of vitamin D status with SARS-CoV-2 infection or COVID-19 severity: a systematic review and meta-analysis. Adv Nutr. Published online March 5, 2021. doi:10.1093/advances/nmab012

3. Petrelli F, Luciani A, Perego G, Dognini G, Colombelli PL, Ghidini A. Therapeutic and prognostic role of vitamin D for COVID-19 infection: a systematic review and meta-analysis of 43 observational studies. J Steroid Biochem Mol Biol. Published online March 5, 2021.

4. Meltzer DO, Best TJ, Zhang H, et al. Association of vitamin D levels, race/ethnicity, and clinical characteristics with COVID-19 test results. JAMA Netw Open. 2021;4(3):e214117. doi:10.1016/j.jsbmb.2021.105883

5. Manson JE, Cook NR, Lee IM, et al; VITAL Research Group. Vitamin D supplements and prevention of cancer and cardiovascular disease. N Engl J Med. 2019;380(1):33-44. doi:10.1056/NEJMoa1809944

A higher prevalence of vitamin D deficiency in people of color may be contributing to a higher burden of COVID-19 in minority populations. Dermatologists are encouraged to address vitamin D status in patients and recommend supplementation, which might have other health benefits. 

COVID-19 Increases Urgency of Addressing Vitamin D Deficiencies in Patients With Skin of Color

Novan announced the results from B-SIMPLE4 (NCT04535531), a multi-center, double-blind, randomized, vehicle-controlled, phase 3 study evaluating the safety and efficacy of SB206 (Novan) for the treatment of patients with molluscum contagiosum. Molluscum contagiosum affects 6 million people in the United States, with highest incidence in children 1 to 14 years. 

The study enrolled 891 patients randomized 1:1 across 55 clinical sites. Each patient received treatment for 12 weeks and had a follow up visit at week 24. 

“The positive results from B-SIMPLE4 represent a transformational milestone for our employees, investors and most importantly, people living with molluscum. The strong safety and statistically significant efficacy results give us confidence as we move forward in preparing a New Drug Application to potentially bring SB206 to market and to patients in need of an effective therapy,” said Paula Brown Stafford, president and CEO of Novan, in Durham, North Carolina. “We owe a great deal of gratitude to the collaborative efforts of our employees, partners, CROs, study investigators and participating patients who have contributed or participated in B-SIMPLE4.”

The primary endpoint of the trial was a proportion of patients with complete clearance of molluscum lesion at week 12. Of the 444 patients who were a part of the SB2016 treatment arm, 32.4% were clear by week 12 compared to 19.7% of the patients treated with vehicle. 

The secondary endpoints were a proportion of patients who achieved a lesion count of 1 or 0 at week 12. Results showed the proportion achieving 90% or more clearance of lesions at week 12, and the complete clearance of lesions at week 8. The SB206 also outperformed the vehicle cream on all secondary endpoints. 

“These results are a testament to Novan’s solid execution of the SB206 clinical program and strategy, and our belief in the potential of SB206 to provide patients with treatment benefit. With 32% of patients experiencing total clearance at week 12 and 43% of patients with total clearance or one remaining lesion at week 12, I am pleased to say the data demonstrate SB206 can be a powerful treatment option to shorten the duration of this contagious disease with visible skin lesions that worry parents and caregivers,” said Tomoko Maeda-Chubachi, MD, PhD, MBA, senior vice president of Medical at Novan, in Durham, North Carolina.

Currently, there are no FDA approved treatments for molluscum contagiosum. 

“I am proud to have been an investigator in this pivotal study. The results are better than I could have imagined. I am excited to potentially have a topical treatment that is safe and effective in treating molluscum for my patients,” said John Browning, MD, FAAD, FAAP, MBA, adjunct associate professor of pediatrics and dermatology at University of Texas Health San Antonio and Baylor College of Medicine, in San Antonio, Texas, and a principal investigator in the B-SIMPLE4 study.

1. Thomas J. Novan Reports Positive Topline Results from Pivotal Phase 3 Trial of SB206 in Patients with Molluscum Contagiosum. Published online June 11, 2021.

The B-SIMPLE4 phase 3 trial achieved positive efficacy results for the treatment of molluscum contagiosum. 

Molluscum Contagiosum Treatment Demonstrates Success in Phase 3 Trial

At the Symposium for Cosmetic Advances and Laser Education (SCALE) Acne and Rosacea Update, Emmy Graber, MD, board certified dermatologist and founder of the Dermatology Institute of Boston, and affiliate clinical instructor, Northeastern University, Boston, Massachusetts presented new updates on the treatments of these conditions.

On updated included sarecycline as a potential treatment for rosacea. Sarecycline is already FDA approved for acne, but it is a new treatment for rosacea.

 The objective of the prospective, parallel-group, randomized, investigator-blinded, pilot study of oral sarecycline was to examine its efficacy and safety in adults with moderate to severe papulopustular rosacea. 

There were 102 patients enrolled in the study with 72 of those patients being treated with oral sarecycline and 25 with placebo. The coprimary endpoints included the percentage of patients with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at week 12 and a reduction of inflammatory lesions. 

Secondary endpoints were a percentage of patients with IGA scores of 0 or 1 at weeks 4 and 8, a percent reduction of inflammatory lesions at weeks 4 and 8, and Subject Global Assessment (SGA) rating at each visit. Researchers also looked for any adverse events (AEs) and local signs and symptoms on the skin. 

At weeks 4, 8, and 12, sarecycline outperformed placebo in the percentage of patients with IGA 0/1. At week 12, 75% of patients had scores of IGA 0/1 in the sarecycline arm vs 16% of the placebo arm. 

For AEs, all were resolved except for a mild case of nausea and a headache by the end of the study. 

For updates in acne, a retrospective study investigating oral spironolactone (Aldactone; Pfizer),evaluated 403 female adult patients with acne.

Results of the study suggested that spironolactone maintains its efficacy even with long-term use. Also, 23% of discontinuations were due to AEs, 6 of which were related to menstrual issues, and the other 15 were due to symptoms such as dizziness, headache, frequent urination, fatigue, dry skin, anxiety, and abdominal pain. 

There was also an update on isotretinoin dosing.

 There was a retrospective review of patients revieing either 1 or 2 courses of isotretinoin. Patients who received 2 courses tended to have a lower cumulative dose and a shorter duration of isotretinoin treatment after acne clearance.

According to Graber, this suggests a cumulative dose and duration of treatment after clearance are strong predictors of acne relapse. The authors of the study recommended treating until culminative dose of 120 – 150 mg/kg for 6 months, and extended treatment for 1 to 2 months. 

The full SCALE conference will be happening in Nashville, Tennessee from August 18 through 22. 

1. Gold M, Graber E, Sawyer, T. SCALE UP Your Practice Webinar: Acne and Rosacea Update. Presented at the: Acne and Rosacea Update; June 9, 2021.

2. Rosso JQ, Draelos ZD, Effron C, Kircik LH. Oral sarecycline for treatment of papulopustular rosacea: results of a pilot study of effectiveness and safety. J Drugs Dermatol. 2021;20(4):426-431. doi:10.36849/JDD.2021.5923

3. Garg V, Choi JK, James WD, Barbieri JS. Long-term use of spironolactone for acne in women: A case series of 403 patients. Journal of the American Academy of Dermatology. 2021;84(5):1348-1355. doi:10.1016/j.jaad.2020.12.071

4. Tran PT, Berman HS, Leavitt E, Hogeling M, Cheng CE. Analysis of factors associated with relapse in patients on their second course of isotretinoin for acne vulgaris. J Am Acad Dermatol. 2021;84(3):856-859. doi:10.1016/j.jaad.2020.10.030

E. Graber, MD has received grants/research support from Sebacia, Ortho Dermatologics, Hovione, consulting fees from SolGel, Verrica, Sebacia, Hovione, Almirall, Digital Diagnostics, a part of the speakers bureau for Almirall, and royalty holder for Walter Kluwer Health.

Emmy Graber, MD, presented the updates in acne and rosacea treatments at the SCALE Acne and Rosacea update on June 9, 2021. 

What’s New in Acne and Rosacea for 2021?

The FDA has approved StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in marine collagen – dsat; Mallinckrodt) for the treatment of thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) in adults.

This approval makes StrataGraft the first approved donor site-free substitute to autograft for deep partial-thickness burns. StrataGraft is designed to handle like an autograft and promote the body’s healing process to achieve definitive closure of a majority of treated wounds, according to a press release.

While autografting is effective in providing closure of the original wound in patients with deep partial-thickness burns, it can lead to donor site complications, including pain, itching, increased risk of infection, and scarring," said Tracee Short, MD, burn surgeon and burn unit medical director at the Regional Burn Center at Baton Rouge General, Baton Rouge, Louisiana. "The approval of StrataGraft represents an important advancement in the treatment of patients with deep partial-thickness burns. Burn surgeons will now have a new biologic treatment to eliminate or reduce the need for autografting.

The approval is backed by positive data from a phase 3 clinical trial, STRATA2016 (NCT03005106), investigating a single application of StrataGraft in patients with acute thermal burns containing intact dermal elements involving 3-37% of the total body surface area (BSA). 

Results demonstrated significantly smaller area of burn wounds treated with StrataGraft required autografting by 3 months vs the area of burn wounds treated exclusively with autograft (p < .0001), according to the release.

Of the 71 StrataGraft-treated burn sites across all participants, 68 (96%) did not require autografting. Also, researchers found the difference in the percent area of StrataGraft and control autograft treatment sites that required autografting by 3 months was 98% (p < .0001). Patients who achieved durable closure of the StrataGraft treatment site at 3 months without autograft placement was 83% (95% CI: 74, 92). Additionally, patients who achieved durable closure of the autograft control treatment site at 3 months without additional autograft placement was 86% (95% CI: 78, 94).

The safety profile of StrataGraft consisted of erythema, swelling, local warmth and wound site infections, and was comparable to autografting in clinical studies. The most common (>2%) adverse reactions (AEs) were pruritus, blisters, hypertrophic scarring, and impaired healing. Also, there were no reports of rejection to StrataGraft and no patients discontinued due to adverse reactions.

"Today's FDA approval of StrataGraft marks a significant milestone for the burn care community and underscores our unwavering commitment and ability to bring paradigm-changing treatment options to patients with severe and critical conditions," said Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt. "We are deeply appreciative of the patients who participated in the StrataGraft clinical trials, the physicians and study investigators involved in the clinical development program, and our employees, who have worked tirelessly over the last 20 years to help us bring StrataGraft to burn surgeons and the patients they treat." 

Mallinckrodt plans on evaluating StrataGraft in pediatric populations and in adults with full-thickness burns (third-degree burns).

1. plc M. Mallinckrodt announces u. S. Fda approval of stratagraft (Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen - dsat). Accessed June 16, 2021. https://www.prnewswire.com/news-releases/mallinckrodt-announces-us-fda-approval-of-stratagraft-allogeneic-cultured-keratinocytes-and-dermal-fibroblasts-in-murine-collagen---dsat-301313193.html

Mallinckrodt announces the FDA approval of StrataGraft (allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen – dsat) for the treatment of adults with thermal burns.

StrataGraft Approved for Thermal Burns in Adults

Podcasts

This episode dives into how health care policy impacts gender and sexual minority patients, including exploring the Affordable Care Act (ACA) and Medicaid expansion, and identifying state and federal nondiscrimination protections that help defend equal access to health care for this patient population. 

The Cutaneous Connection: Episode 25- How Health Care Policy Impacts Gender and Sexual Minority Patients

Nutrafol announced today the release of a new nutraceutical targeting postpartum hair loss in women.

The new addition to their product is called Nutrafol Postpartum and it is an OBGYN-developed postpartum hair nutraceutical, according to a press release announcing the supplement.

Nutrafol Postpartum’s goal is to help women who experience postpartum hair loss grow thicker and fuller hair. This is achieved by helping the body recover from multiple stresses, like childbirth and motherhood, while also filling any gaps in nutrition with natural ingredients. 

Around 50% of women experience postpartum hair thinning and shedding starting at about 3 months post-birth and can last up to 6 months, according to the release. The hair does return, but it can lack thickness and, in some cases, grow in thinner due to the hair growth cycle returning to its pre-pregnancy state. The hair growth cycle resets after about 6 to 15 months. 

“Women can begin using Nutrafol Postpartum immediately after childbirth through their first year postpartum. We recommend taking the product for 3-6 months and beyond to support recovery and replenish the body to promote better hair growth,” Anne Kennard, DO, FACOG, Dipl-ABLM, a board-certified obstetrician gynecologist, San Luis Obispo, California, told 

®. “If patients are still breastfeeding after the first year, we recommend continuing with Nutrafol Postpartum. Once they’ve stopped breastfeeding, they can switch to Nutrafol Women.”

Kennard helped develop Nutrafol Postpartum because of her experience as both an OBGYN and a mother. There were not products targeting the root causes of hair thinning until this point, she says, and after giving birth, women can be very cautious about what ingredients they put into their bodies. 

Product ingredients include nettle, pea sprouts, shatavarti, and Omega3s. The ingredients are from whole-food sources and provide nutritional support within the Recommended Dietary Allowances (RDA) and Tolerable Upper Intake Level (UL) values set by the FDA with no ingredients found to be contraindicated in breastfeeding and is compatible with most prenatal vitamins and multivitamins, according to Kennard. 

“Postpartum hair shedding is so common,” Kennard says. “According to the American College of Obstetrics and Gynecology, most women experience it. Remind your patients that they are not alone, and there is now a natural way to support their hair growth recovery with clinically-tested, breastfeeding-friendly ingredients.” 

Kennard helped develop Nutrafol Postpartum.

Leff L. Sneak peak of new launch from Nutrafol. Published online June 15, 2021. Accessed June 15, 2021. https://www.prnewswire.com/news-releases/nutrafol-drives-hair-health-innovation-with-new-postpartum-supplement-301313177.html

Nutrafol launches a new nutraceutical, called Postpartum, aimed at helping women’s hair health post-pregnancy. 

Nutrafol Launches Postpartum Nutraceutical

Ortho Dermatologics, a Bausch Health Company, announced results from its second phase 3 trial (NCT04214652) investigating the safety and efficacy of IDP-126 (Ortho Dermatologics)) for the treatment of acne vulgaris in patients 9 years and older.

This study, a phase 3, multicenter, randomized, double-blind, vehicle-controlled trial, met all coprimary endpoints by week 12.

The endpoints were the absolute change from baseline in inflammatory lesion count and noninflammatory lesion count, and percentage of patients who achieved treatment success. The treatment success was defined as clear or almost clear skin in the Evaluator’s Global Severity Score (EGSS). 

“Most acne patients are treated with a regimen that includes several different classes of medicine because of the complicated nature of the disease. This approach can be cumbersome for patients and exacerbate poor adherence rates, which are already low for acne patients when using simple regimens,” said Scott Hirsch, president of Ortho Dermatologics, and senior vice president and chief strategy officer of Bausch Health, Laval, Canada. “Dermatologists have been asking for a triple combination therapy to help them combat this issue for decades. Ortho Dermatologics has achieved a technological breakthrough with IDP-126 to deliver on this need, which, if approved, will provide the first and only triple combination treatment option to help patients struggling with acne.”

Results from the study were based on 193 patients, 9 years and older, that participated in the trial. The patients were randomized to receive IDP-126 gel or vehicle once daily for 12 weeks.

Out of the two treatment arms, 50.5% of the IDP-126 arm achieved EGSS clear or almost clear compared to 20.5% vehicle. Some patients achieved benefits from treatment as early of 2 weeks. 

The treatment emergent adverse events (TEAEs) that were reported in less than 2% of patients such as application site pain, dryness, irritation, erythema, exfoliation, and xerosis. 

“The impressive results of this second phase 3 study for IDP-126 are consistent with the results seen in the findings from the first Phase 3 study, particularly the strong efficacy results. I am encouraged that, if approved, IDP-126 will deliver a triple-combination therapy – three active ingredients in one product – which could simplify the treatment regimen and have a meaningful impact on my patients suffering from acne,” said Linda Stein Gold, MD, director, Dermatology Clinical Research, Henry Ford Health System, Detroit, Michigan.

If approved, IDP-126 would be the first treatment that is a combination retinoid, antibacterial and antibiotic topical. 

1. Marks K. Ortho Dermatologics announces statistically significant topline results from second pivotal phase 3 clinical trial evaluating idp-126 gel in acne vulgaris. Published online April 27, 2021.

IDP-126, an acne vulgaris treatment for patients ages 9 and older, met all of its endpoints in a 12-week phase 3 study. 

IDP-126 Meets Endpoints in Second Phase 3 Study

Five years of innovation and research have created numerous knowledge gaps in the American Academy of Dermatology (AAD) guidelines of care for the management of acne vulgaris.

A work group recently formed by the academy to update its guidance will offer best-practice recommendations and safety precautions for the therapies, treatments, and devices developed to treat acne. Originally published in 2016, the new guidelines will be released in 2023 or 2024.

“Two major concerns are proper dosing of isotretinoin and laboratory monitoring for spironolactone and isotretinoin,” said Jonette Keri, MD, PhD, FAAD, associate professor of dermatology and cutaneous surgery at the University of Miami Miller School of Medicine in Florida, dermatology service chief at Miami VA Medical Center, and a member of the work group. “The updates will also provide guidance on new antibiotics and antibiotic stewardship as well as a broader knowledge of lasers and other light devices in use for acne treatment.”

She offered insights into the upcoming revisions in the AAD’s acne guidance as forum director for a session on translating evidence in practice for current acne guidelines and beyond at the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX) in April.

Fellow speakers included Arun L. Pathy, MD, FAAD, dermatologist with Colorado Permanente Medical Group in Centennial and cochair of the work group revising the AAD acne guidelines

; Rachel Sabbag Reynolds, MD, vice chair, Department of Dermatology, and assistant professor of dermatology, Harvard Medical School, in Boston, Massachusetts

 Jonathan S. Weiss, MD, dermatologist with Georgia Dermatology Partners and Gwinnett Clinical Research Center in Snellville, Georgia

; and Andrea Zaenglein, MD, FAAD, professor of dermatology and pediatric dermatology at the Milton S. Hershey Medical Center at Penn State University in Hershey, Pennsylvania.

“In developing these new guidelines, not only have we recruited acne experts around the country, but we have an internal medicine physician, a pediatrician, and a patient advocate,” Keri said. “In fact, more than 51% of the work group does not have any relevant pharmaceutical interest. This is important because acne is not just treated by dermatologists. Primary care takes an active role, so we need to consider their view, as well as that of the patients.”

Keri told Dermatology Times® that there is always going to be room for improvement in the treatment of acne. “At least [for now], we do not have a magic bullet that gets rid of acne 100% for 100% of a person’s life,” she said. 

However, the treatment option pipeline continues to flow, focusing on care until cure is a reality. New to the list of topical formulations are a minocycline foam (Amzeeq; Foamix Pharmaceuticals) and a retinoid, trifarotene (Aklief; Galderma).

“There are also new formulations of older retinoids, which have been evaluated [and found] to be helpful,” Keri said. “In addition, clascoterone [Winlevi; Cassiopea] is a new topical antiandrogen that is approved by the FDA but not yet released for use. This drug should be available soon.”

Sarecycline (Seysara; Almirall) is the first new oral antibiotic approved by the FDA in more than 40 years. One of its added benefits is that this tetracycline-derived small molecule drug is “less likely to generate resistance,” Keri said. “This is exciting because of the goal for antibiotic stewardship around the world.” 

Patients also need to be educated about new oral antibiotics that are weight-based. “We have this stipulation with some antibiotics, but not for all of them,” Keri said. “Antibiotic stewardship ensures that you have the right antibiotic and the correct dose at the right time for the correct condition. You want to make sure that you are not giving too much or not enough.”

In Keri’s view, the dermatology community is working diligently to reduce its reliance on antibiotics. “As we get new mechanisms to treat acne, perhaps we can use fewer antibiotics,” she said.

The forum included a review of oral contraceptives approved for treating acne, as well as highlights of some of the controversies about adverse effects, including thromboembolic events with certain oral contraceptive pills and their safety.

“Currently, there are 4 FDA approved oral contraceptive pills for the treatment of acne, but there are many birth-control pills that are not FDA approved for the treatment of acne [that] can help,” Keri said.

Most of the oral contraceptive pills, whether they are approved or not for treating acne, are a combination of estrogen and progesterone. “Clinicians need to understand the difference of these 2 components, so they can make an informed decision about prescribing to their patients for acne,” Keri said. “There are oral contraceptive pills that are good for acne; however, these companies did not pursue approval for the treatment of acne.”

Keri tends to prescribe FDA-approved oral contraceptives that contain drospirenone (Yaz; Beyaz; Bayer) because the synthetic progestin acts as a potent antiandrogen. “However, there is a little controversy about their [adverse] effect profile, specifically thromboembolic events,” she said. “But the risk is slight.”

Spironolactone also is an antiandrogen used in adult women. “It has gained a lot of acceptance over the years for the treatment of acne, due in part to celebrity endorsement,” Keri said. “One of the [adverse] effects of spironolactone in men is gynecomastia, so it is not used in treating acne in males.”

Excellent results are achieved with spironolactone, according to Keri, with long-term treatment lasting for years. Laboratory monitoring may be required, however, because the medication can cause hyperkalemia, an increase in potassium.

Isotretinoin is a vitamin A derivative for severe scarring with nodular cystic acne or for acne that causes severe psychological implications for the patient. However, the systemic medication is surrounded by controversy over serious adverse effects, including malformations in the fetus. 

“That [adverse] effect [teratogenicity] is undisputed, unlike concerns of depression and inflammatory bowel disease,” Keri said. “In the past, I believe people were simply being cautious about prescribing isotretinoin. Now, however, because of good epidemiologic studies, dermatologists are feeling increasingly comfortable about prescribing the drug.”

At Keri’s practice, dosing of isotretinoin is patient preference, although she favors typical cumulative dosing to 150 mg/kg. “But there are patients who need more of the drug or less,” Keri said. “There is variability in how much isotretinoin patients will need, and we are working to define the optimal dose for patients.”

Diet has become increasingly important in treating acne as well. “There is some evidence that milk aggravates acne,” Keri said. “Although some data suggested skim milk was more implicated, recent data does not support this. The jury is still out on the association between of milk and acne.”

“White” foods with a high glycemic load, such as white bread, rice, and pasta, also have been strongly implicated in exacerbating acne. “My patients tend to place too much emphasis on diet, although diet can be a contributor to acne,” Keri said. “Diet is more concerning for the female patient with polycystic ovarian disease. Diet intervention [watching the glycemic load/index] has been proven to help these patients specifically.”

The advantages of light-based devices vs traditional pharmaceutical therapies are also changing the acne treatment paradigm. Traditional treatments still tend to be first-line choices, but light- and laser-based therapies can be used for the patient who does not want traditional treatment or has failed traditional therapy and is able to pay the out-of-pocket expense—it’s generally not covered by insurance, according to Keri.

Other research gaps for acne include treating patients with skin of color and pregnant patients, as well as exploring the molecular and cellular mechanisms underlying acne.

“A lot of work goes into the guideline development,” Keri said. “That is why it takes 2 to 3 years. We try to assess the validity of the evidence and attempt to make it user-friendly so that the guidelines can be a reference for the practitioner who is in a busy practice.”

Keri is on the speakers bureau of VYNE Therapeutics and a consultant to Almirall.

Pathy, Sabbag, and Reynolds reported no financial or relevant disclosures.

Zaenglein is a consultant for Pfizer; an advisory board member for Dermata, Sol-Gel, Regeneron, Verrica Pharmaceuticals, and Cassiopea; and a contracted researcher for AbbVie, Arcutis and Pfizer.

1. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-73.e33. doi:10.1016/j.jaad.2015.12.037

2. Keri J, Pathy A, Weiss JS et al. Translating evidence into practice, current acne guidelines and beyond. American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX); April 23-25, 2021; virtual. Accessed May 4, 2021.

3. Pathy A. Guide development and clinical pearls. American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX); April 23-25, 2021; virtual. Accessed May 4, 2021.

4. Sabbag Reynolds. Spironolactone for the treatment of acne. American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX); April 23-25, 2021; virtual. Accessed May 4, 2021.

5. Weiss J. Isotretinoin guidelines. American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX); April 23-25, 2021; virtual. Accessed May 4, 2021.

6. Zaenglein A. Diet and acne. American Academy of Dermatology 2021 Virtual Meeting Experience (AAD VMX); April 23-25, 2021; virtual. Accessed May 4, 2021.