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and joined the MJH Life Sciences team in February 2023. She attended Kent State University and earned a Bachelor of Science degree in journalism with minors in public relations and creative writing. She enjoys making and listening to music, reading, and spending time with her cats, Astrid and Marceline.

Articles

With greater understanding of this rare pathology and its signs and symptoms, review authors believe this understanding could prompt early and necessary intervention.

Greater Understanding Necessary in Treatment of Periorbital Facial Necrotizing Fasciitis, Review Argues

Each of 3 patients treated with cemiplimab achieved a near complete response.

First Real-World Report of Near Complete Response With Cemiplimab in Penile Squamous Cell Carcinoma, Study Confirms

A recent study linked alopecia areata and the presence of cochlear dysfunction in some patients.

Alopecia Areata Linked to Hearing Loss, Study Finds

The sNDA is supported by positive data from the phase 3 INTEGUMENT-1 and INTEGUMENT-2 trials.

FDA Accepts sNDA for Arcutis' Roflumilast Cream 0.15% for Atopic Dermatitis, Sets July 2024 PDUFA Date

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Clinical

This episode highlights findings from an investigative study exploring the molecular targeting of biologics for psoriasis, as well as discusses the interleukin(IL)-17 class of biologics, how this class compares to other classes such as IL-23 and TNFα, and how bimekizumab (UCB) sets itself apart from other biologics in the pipeline for psoriasis.

This episode highlights findings from an investigative study exploring the molecular targeting of biologics for psoriasis, the IL-17 drug class, how bimekizumab is different, plus more.

The Cutaneous Connection: Episode 31- Molecular Targeting of Psoriasis Biologics

Mark Lebwohl, MD, takes a deep dive in the recent delay in approval for multiple JAK inhibitor drugs for treatment of inflammatory skin conditions such as psoriasis and atopic dermatitis. He also discusses the impact of the delay, as well as the benefits of JAK inhibitors for inflammatory skin diseases, and an outlook for the future of this drug class.

The Cutaneous Connection: Episode 30- Impact of the JAK Inhibitor Approval Delays

The FDA’s PDUFA target date is May 25, 2024. 

FDA Grants Priority Review of Abeona’s Pz-cel BLA for Recessive DEB

One notable change: CVS Caremark has removed the Humira biosimilar Amjevita and now prefers Hyrimoz and an unbranded biosimilar.

CVS Removes Biosimilars From Drug List

Jared Gollob, MD, Chief Medical Officer of Kymera Therapeutics, spoke with Dermatology Times to discuss these trial results.

KT-474 Demonstrates Efficacy and Promise in Atopic Dermatitis and Hidradenitis Suppurativa Study

There are currently no FDA-approved therapies for the rare, genetic disease.

FDA Grants Breakthrough Therapy Designation to QTORIN Rapamycin for Microcystic Lymphatic Malformations

The US Food and Drug Administration has approved dupliumab (Dupixent; Sanofi and Regeron Phamaceuticals, Inc.) for the treatment of prurigo nodularis in adult patients.  Dermatology Times© spoke with dermatologists Amy Spizuoco, DO, FAOCD, a dual board-certified dermatologist and owner of True Dermatology in New York, New York and Christopher Bunick, MD. PhD, associate professor of dermatology, Yale Department of Dermatology, to discuss how they believes dupliumab will change the way dermatologists treat prurigo nodularis. 

: This is huge for us in the dermatology community, because patients who have prurigo nodularis suffer from extreme itching and skin lesions andup until now, we've not had anything that's super successful and effective, or FDA approved for the treatment of these conditions. Having dupilumab approved for patients with prurigo nodularis is going to change how I treat patients, because now I have something that is FDA approved and has proven efficacy and safety and tolerability for my patients, as opposed to just kind of, you know, throwing the kitchen sink at them, you know, topical steroids, light treatments, you know, things that aren't super effective and not FDA approved.

: Do you see a lot of patients that are just very frustrated with this condition?

Yes. All over our dermatology community and even in primary care and other specialties. We see tons of patients suffering from this condition, because it's extremely itchy and a lot of them affect their activities of daily living. They can't sleep, they're not concentrating at work, they are not concentrating in school. We see tons of patients suffering with this condition that haven't had good treatment that's effective and safe for them.

: Understood! Is there anything else you want to add?

: Just that I'm really excited that this medication is now going to be approved for our patients suffering with prurigo nodularis. We've seen its efficacy in patients with atopic dermatitis and other conditions in the allergy immunology world. So, it is nice to see that we have something that is approved and is effective for our patients suffering from extreme itch and skin lesions.

1. Study of Dupilumab for the Treatment of Patients with Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (PRIME2). ClinicalTrials.gov identifier: NCT04202679. Updated September 28, 2022. Accessed September 28, 2022.

https://clinicaltrials.gov/ct2/show/NCT04202679?term=PRIME2&cond=Prurigo+Nodularis&draw=2&rank=

2. Study of Dupilumab for the Treatment of Patients with Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME). ClinicalTrials.gov identifier: NCT04183335. Updated February 17, 2022. Accessed September 28, 2022.

https://clinicaltrials.gov/ct2/show/NCT04183335?term=PRIME%2C+dupilumab&draw=2&rank=1

Videos

Sanofi and Regeneron’s dupliumab will provide relief to patients with extreme itch and skin lesions. 

News 

FDA Approves Dupliumab for Prurigo Nodularis  

Alan Mendelsohn, MD, and CMO of Timber Pharmaceuticals in Basking Ridge, New Jersey, discusses recently published study data and abstracts on TMB-001, a topical isotretinoin, for the treatment of congenital ichthyosis. Seven abstracts from Timber Pharmaceuticals were presented at the 31st Annual European Academy of Dermatology and Venereology in Milan, Italy. 

 Hello from Milan. My name is Alan Mendelsohn. I am the Chief Medical Officer of Timber Pharmaceuticals, and I am attending the European Academy of Dermatology and Venereology meetings here, where we have just recently presented 7 abstracts on our control phase 2b study of topical TMB-001, which is a topical isotretinoin compound using proprietary IPEG or polyethylene glycol vehicle mixture in the treatment of x-linked and lamellar ichthyosis. I’m really happy to be at the meeting, really happy to see the advances that are being made, frankly, proudly by Timber. There were 12 abstracts at this meeting on congenital ichthyosis, and 7 of the 12 abstracts came from Timber and support the reasons why we currently have fast track designation and breakthrough designation by the FDA for this compound.

Just to briefly go over the control trial the phase 2b trial itself, this was a 34-patient phase 2b trial, 1-1-1 randomization of low dose TMB-001 0.05%, higher dose 0.1%, and vehicle. In patients 9 years and above, with either x-linked or lamellar ichthyosis, not just the TGM-1 type, but really any of the 8 or 9 other genetic abnormalities which differentiates this trial from potentially other trials. The primary endpoint of the trial was an improvement of 50% in theVIIS or Visual Index for IchthyosisSeverity score. And the major secondary endpoint was a two-point improvement in the IGA or Investigator Global Assessment. What we found in a presented previously in the 

Journal of the American Academy of Dermatology

 is a marked improvement clinically and statistically for those patients who received 0.5% dose compared to vehicle with a very, very tolerable safety profile that really only involve localized skin reactions.

At this meeting, we focused on two different areas of research, the first of which really tries to define best from the trial data which population of patients do best. And then the second area that we looked at, it's really just general information and knowledge that can be used to advance the use of isotretinoin in future trials by us and other companies around isotretinoin utility in congenital ichthyosis. What we reported at this meeting is that basically, age, gender, and body mass index really did not influence response rates to the topical isotretinoin, TMB-001. Patients who responded tend to have slightly less body surface area involvement, but tended to have worse quality of life measurements and worse itch at baseline. So that's a good thing in terms of physicians and health professionals being able to choose the proper patients. We showed that, even though it's well known that patients who receive topical retinoids will have an increased risk of skin reactions and may have to stop and take drug holidays, that, in fact, the vast majority of patients, up to even 3 drug interruptions during the first 12 weeks still have a 50% to 75% chance of fully responding by week 12. And in fact, with no drug interruptions, 100% of those patients respond. And so we've incorporated that into our phase 3 program in terms of changing the induction regimen from twice a day, which is how we've tested it in the phase2a/2b into once a day for the first 3 weeks in the phase 3. We also looked at localized skin reactions and whether that was dose related and in fact found a couple of things, there was really no dose relationship between skin reactions and dose. And more importantly, the vast majority of skin reactions that happen, happen really in the first 2 to 4 weeks. And after 2 to 4 weeks, they tend to resolve, which again, supports our current induction regimen in the phase 3 program which is currently underway.

What we add to the science, both of this meeting and previous meetings is the fact that from a genotype standpoint, and a phenotype standpoint, really doesn't matter if you have x-linked or lamellar disease. In both populations, the Delta, the difference between drug response and vehicle, is identical regardless of which genotype you have. We also show that pediatric and adult patients based on age above and below 18, response rates are nearly identical. What was new at this meeting that we showed was the fact that it's well known with retinoids that they can affect serum concentrations of liver function studies, cholesterol, platelets, white blood cells, and red blood cells. And what we found in this trial was 0.05% dose had no effect at all on hepatic toxicity or causing hepatic toxicity, no evidence of changing cholesterol, no evidence of changing platelets, which again indirectly indicates that we have minimal absorption of the drug, which is exactly what you would want to have with a topical isotretinoin product is basically all of the drugs staying in the skin, where the disease is, and very little getting into the systemic circulation.

The other thing we found that's probably very important, not just to us, but to the entire ichthyosis community and other companies, is the fact that the currently utilized quality of life questionnaires such as the Dermatology Life Quality Index, or the children's DLQI, though patients will report that they have quality life issues, when you actually look at their scores, the vast majority, well over 80% or 85% of patients using these particular questionnaires, say they have no or minimal quality of life issues, even though 90% of their body may be covered by these scales. What we did find, however, is that patients who had significant quality of life inhibition showed a marked significant improvement in their quality of life. And so we're using a different quality of life questionnaire in our phase 3 program, which I think is important for the community to understand. We're very excited about the phase 3 program. It's currently underway in the United States and will shortly open hopefully, in Canada and in 3 European countries. We are very excited about the future. We're very excited about being able to bring a treatment to a disease that has an unmet need. And as always, I thank from the bottom of my heart, all of the subjects, the patients who have enrolled and will hopefully enroll in this trial and all of the investigators that have helped us to get to this point. Thank you for your time.

TMB-001 showed positive results in the reduction of congenital ichthyosis severity in a phase 2b CONTROL study. 

Timber Pharmaceuticals Presents CI Study Data at EADV Congress 

With no current FDA-approved treatments for molluscum contagiosum, Stephen Stripling, MD, FAAP, and co-medical director at Coastal Pediatric Research in Charleston, South Carolina, explains the importance of the JAMA berdazimer gel 10.3% study

 and the hope it provides for patients and their families.

Browning JC, Enloe C, Cartwright M, et al. Efficacy and Safety of Topical Nitric Oxide−Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. 

 Published online July 13, 2022. doi:10.1001/jamadermatol.2022.2721

Results published in the Journal of the American Medical Association (JAMA) Dermatology detailed the efficacy and safety of berdazimer gel 10.3%, in the treatment of molluscum contagiosum. 

Stephen Stripling, MD, FAAP, Discusses Study of Berdazimer Gel for Molluscum Contagiosum

Lindsey Savickas, RN, BSN, and COO at Infusion Associates, explains how infusion centers can support researchers in the dermatology space in discovering more effective treatments. 

How Infusion Centers Support Dermatology Research

board member, and Seemal R. Desai, MD, FAAD, highlight the vitiligo pipeline. 

The topic of the potential treatment ruxolitinib (Opzelura; Incyte), which the FDA granted Priority Review and has a Prescription Drug User Fee Act (PDUFA) target action date is April 18, 2022, as the first FDA approved therapy for vitiligo is brought up along with the costs of this treatment. Watch the full discussion below. 

In this drug pipeline video, Pearl Grimes, MD, FAAD, and Seemal R. Desai, MD, FAAD discuss what's currently happening in the vitiligo pipeline including why current treatments are lacking, what's coming soon, and what it may cost. 

What's Happening in the Vitiligo Pipeline?

Patients saw a reduction in scaling and fissuring with 

 regardless of the subtype of congenital ichthyosis (CI), according to a presentation at the American Academy of Dermatology's 2022 Annual Meeting. 

In a late-breaker presentation and in a subsequent interview with

, Christopher Bunick, MD, PhD, of Yale University, discussed the results of a subanalysis of the phase 2B Control study. 

"The medication was quite safe and importantly, there was no significant absorption to the bloodstream, despite [the patients] using it on 73.5% of body surface area. 

In this video interview, Christopher Bunick, MD, PhD dives into the topic of congenital ichthyosis describing his talk on the skin condition at the American Academy of Dermatology 2022 Annual Meeting. 

 Late Breaking Research: Congenital Ichthyosis

Dermatology Times® interviews editorial board member Richard Gallo, MD, PhD, chair of dermatology at the University of California-San Diego, in San Diego, California, about what's happening in the rosacea drug pipeline. In this video interview, Gallo talks about what's new in treatment, how certain rosacea phenotypes are harder to treat than others, and what is being done to addresss these issues. 

Dermatology Times® interviews editorial board member Richard Gallo, MD, PhD, who dives into what is currently lacking is rosacea patient care, how the new mechanisms of action of these potential treatments will better address current struggles, and more. 

Drug Watch: What's Coming in the Rosacea Pipeline

Dustin Portela, DO, a board-certified dermatologist and dermatologic surgeon at Treasure Valley Dermatology in Boise, Idaho, interviews Marvin Rapaport, MD, a board-certified dermatologist at Rapaport Dermatology of Beverly Hills. In this interview, they discuss the potential complications that arise from overuse of topical steroids. See the educational discussion they have in the video below.

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

In this week’s Pointers with Dr Portela, the 208SkinDoc has a discussion with Marvin Rapaport MD, about the potential adverse events that may occur when patients overuse topical steroids. Watch the interview, meant for educational purposes only, to see what they had to say. 

Pointers with Dr Portela: Topical Steroid Withdraw

A recent mouse model study on the efficacy of using imatinib as a treatment for Sturge Weber Syndrome has been published. In this video interview we talk with one of the investigators, Jack L. Arbiser, MD, PhD, on what the results means for future clinical trials. 

Study into New Possible Treatment of Sturge Weber Syndrome

At the 2022 Winter Clinical Dermatology Conference, Ted Rosen, MD, professor of dermatology at Baylor College of Medicine and chief of dermatology at the Houston VA medical center in Houston, Texas, gave the presentation, "What's Hot and New in Infectious Disease?" Here he dives into the details of infectious disease and explains what some physicians may miss.

What new treatments are coming to infectious disease? How can they be prevented and what misconceptions are affecting treatment? Learn about this and more in this video with Ted Rosen, MD.

Drug Watch

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