Vial’s Medical Director Dr. Janet Dubois on her recent Tapinarof cream research

I am a Board Certified Dermatologist with over 30 years of experience, most of which I have spent caring for patients in Austin, Texas. My formative years were spent in New England, originally in Connecticut, and then completing my undergraduate education at Smith College, Northampton, Massachusetts. After college, I moved to Texas with some friends and was accepted to the University of Texas, Medical School at San Antonio. 

I was first exposed to research during my residency at Case Western Reserve University in Cleveland, Ohio, and found it to be a refreshing change from the busy patient clinics. After moving back to Texas in 1994 and a few years in private practice, I was approached by the previous owners of DermResearch, Inc. to collaborate with them. I was excited at the prospect of getting back into the world of clinical research in addition to my clinical practice duties. While at DermResearch, I have been the principal investigator on over 200 studies, Phase 1 through Phase 4. It has been very rewarding to be at the forefront of innovative research in Dermatology. Clinical research differs greatly from private practice, as it focuses on gathering data to improve the lives of patients collectively, instead of treating patients individually. In addition, I have enjoyed the intellectual challenge of using the pathophysiology of disease and mechanisms of action of drugs to bring new treatments to fruition through clinical research of the highest quality. 

In order to bring research data to the scientific community, it must be published in a scientific journal, which may take some time from initiation to publication.  The sponsor of the research is usually the initiating party in this process. The investigator conducting the study may also do so with the permission of the sponsor. Drafts of the manuscript are created by professional medical writers who then send them to the authors for review and comments. Once the final draft is completed to the authors’ satisfaction, it is submitted to a journal for publication. As each journal has its own guidelines for publication, the draft may have to be altered to suit the requirements, and questions posed by the reviewers must be answered by the authors. On acceptance of the manuscript for publication, the lead author or corresponding author communicates with the journal representatives and reviews the galley proof for final approval. 

My most recent research article, “Tapinarof Cream 1% for Extensive Plaque Psoriasis: A Maximal Use Trial on Safety, Tolerability, and Pharmacokinetics” published in the American Journal of Clinical Dermatology, demonstrates the safety of a new class of topical drugs. Inflammatory skin diseases, such as psoriasis and atopic dermatitis, have traditionally been treated with topical corticosteroids. While corticosteroids are effective for most, the more potent varieties can only be applied to certain parts of the body and to a limited amount of the body surface because of the risk of absorption and potential systemic side effects. Frequent use of topical steroids can also have long-term side effects on the skin, making it thinner and more susceptible to damage. There is currently no cure for psoriasis or atopic dermatitis, and there is a need for an effective topical treatment that can safely be used over large or sensitive areas without the worry of severe local or systemic adverse effects.

The aryl hydrocarbon receptor (ARH) is involved in the regulation of inflammatory responses of the body. Tapinarof 1% (Dermavant Sciences) is a novel topical aryl hydrocarbon receptor modulating agent being studied for its therapeutic effects on psoriasis and atopic dermatitis. In order to investigate the absorption of the drug into the bloodstream when it is applied to extensive body surface areas (≥ 20% BSA), we conducted a maximal use study. Potential systemic side effects of absorption from extensive areas may also be uncovered by these studies. 

The participants of the study applied tapinarof 1% cream once daily to their psoriasis and were evaluated for safety and tolerability, pharmacodynamics, cardiodynamics, and efficacy. Our findings show that most participants tolerated the cream well even in sensitive areas, such as body folds. Adverse effects reported included headaches and some local reactions (primary folliculitis). Although the study was not designed to specifically evaluate efficacy, it has provided some promising data. Furthermore, results of Phase 3 trials that were published in the New England Journal of Medicine in December 2021, demonstrated the superiority of tapinarof 1% cream to vehicle cream for mild-to-moderate psoriasis involving 3 to 20% body surface area. The findings of our study, along with those of the Phase 3 trials, have provided evidence that tapinarof has the potential for fulfilling the need for a topical treatment option that is effective and safe to use without restrictions on application sites, extent, or duration of use.

About Vial:

Vial’s mission is to run clinical trials with faster execution and higher quality in order to bring new therapies to market. Vial has over 70 employees and is based in San Francisco, California. Vial partners with Dermatologists to support their research teams and has created a network of over 35 Dermatology clinics. The Vial network has contributed to over 150 trials for many of the leading sponsors in Dermatology having run trials across common Medical Dermatology indications (Atopic Dermatitis, Psoriasis, Vitiligo, Alopecia Areata, Rosacea, Hidradenitis Suppurativa, Prurigo Nodularis among others) as well as Aesthetic Dermatology indications. The clinic network runs trials from Phase I through Phase IV.

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