6 Participants Needed

Tapinarof for Palmoplantar Keratoderma

BM
FL
Overseen ByFlossy Lincoln
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to assess adults with palmoplantar keratoderma (thickening skin layer on palms and soles) who are treated with the study drug, tapinarof. This is a naturally occuring compound used for the treatment of psoriasis. This study is being done to find out how well and safe this drug is for stopping or treating keratoderma. This study aims to investigate the positive impacts of daily topical Tapinarof use in the improvement of Keratoderma. Clinical efficacy and safety profile of prescribing Tapinarof for this condition will be evaluated.

Will I have to stop taking my current medications?

If you are using topical corticosteroids, keratolytic agents, topical retinoids, topical vitamin D ointment, or oral retinoids, you will need to stop taking them and have a 2-week period without these medications before starting the study.

What data supports the effectiveness of the drug Tapinarof for treating skin conditions?

Tapinarof has shown promising results in treating plaque psoriasis, with significant improvements observed in clinical trials. It works by activating certain receptors in the skin that help regulate immune responses and maintain skin health.12345

Is Tapinarof safe for use in humans?

Tapinarof cream has been tested in clinical trials for conditions like plaque psoriasis and has shown a favorable safety profile. Common side effects include folliculitis (inflammation of hair follicles), contact dermatitis (skin irritation), and headache, but no new safety concerns were identified in extended trials.12367

How is the drug Tapinarof unique for treating Palmoplantar Keratoderma?

Tapinarof is unique because it is a non-steroidal topical cream that works by activating aryl hydrocarbon receptors, which help regulate the immune response and maintain skin health. This mechanism is different from traditional treatments like corticosteroids, which can have more side effects.12456

Research Team

DR

David Rosmarin, MD

Principal Investigator

Dermatology

Eligibility Criteria

This trial is for adults with palmoplantar keratoderma, a condition where the skin on palms and soles thickens. Participants should be diagnosed with this condition to qualify. The study will exclude certain individuals based on criteria not specified here.

Inclusion Criteria

Ability to discern and provide written informed consent and voluntarily adhere to all of the protocol requirements
I have been diagnosed with palmoplantar keratoderma.

Exclusion Criteria

I will use topical corticosteroids during the study.
Currently participating in another clinical study for the same purpose
I am not using skin treatments like salicylic acid during the study.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period

16 weeks
4 visits (in-person)

Extension

Participants who do not achieve disease clearance continue treatment for up to 36 additional weeks or until clearance is achieved

Up to 36 weeks

Follow-up

Participants are monitored for sustained response and recurrence of keratoderma up to 52 weeks

52 weeks
Regular follow-up visits

Treatment Details

Interventions

  • Tapinarof
Trial Overview The trial is testing Tapinarof, a natural compound used in psoriasis treatment, to see if it's effective and safe for treating palmoplantar keratoderma when applied daily as a topical medication.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Tapinarof Drug TreatmentExperimental Treatment1 Intervention
Subjects in this arm will apply Tapinarof 1% cream topically once daily for a 16-week open-label treatment period. Participants who achieve disease clearance after 16 weeks may discontinue treatment and will be monitored for sustained response up to 52 weeks. Those who do not achieve clearance will continue the treatment during an extension period for up to 36 additional weeks or until clearance is achieved, whichever comes first. Regular follow-up visits will assess the duration of disease clearance and monitor for any potential recurrence of keratoderma.

Tapinarof is already approved in United States for the following indications:

🇺🇸
Approved in United States as Vtama for:
  • Plaque psoriasis in adults
  • Atopic dermatitis in adults and pediatric patients 2 years of age and older

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Dermavant Sciences, Inc.

Industry Sponsor

Trials
9
Recruited
1,800+

Findings from Research

Tapinarof (VTAMA®) 1% cream is an effective new treatment for plaque psoriasis, showing significant improvement in 35.4% to 40.2% of patients compared to only 6.0% to 6.3% in the placebo group over 12 weeks in phase 3 trials.
The mechanism of action involves tapinarof activating aryl hydrocarbon receptors, which help regulate immune response and maintain skin health, although some patients experienced mild adverse effects like folliculitis and headaches.
VTAMA® (Tapinarof) Cream* for Plaque Psoriasis.Gupta, AK., Ravi, SP., Vincent, K., et al.[2022]
Tapinarof, a new topical treatment for plaque psoriasis, was approved by the FDA in May 2022 and has shown proven efficacy and safety in clinical studies, making it a promising option for adults with this condition.
Unlike traditional topical corticosteroids, which can have adverse effects and limitations, tapinarof offers a novel mechanism of action by modulating the aryl hydrocarbon receptor, potentially improving patient care in managing psoriasis.
A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults.Kalabalik-Hoganson, J., Nogid, A., Frey, K.[2023]
Tapinarof cream 1% is a topical treatment that acts as an aryl hydrocarbon receptor (AhR) agonist, which plays a role in regulating immune responses in the skin, and it has been approved in the USA for treating plaque psoriasis in adults.
The cream is also being studied for its effectiveness in treating atopic dermatitis, indicating its potential as a versatile treatment for various skin conditions.
Tapinarof Cream 1%: First Approval.Keam, SJ.[2022]

References

VTAMA® (Tapinarof) Cream* for Plaque Psoriasis. [2022]
A Review of Tapinarof: Novel Topical Treatment for Plaque Psoriasis in Adults. [2023]
Tapinarof Cream 1%: First Approval. [2022]
Efficacy and patient-reported outcomes from a phase 2b, randomized clinical trial of tapinarof cream for the treatment of adolescents and adults with atopic dermatitis. [2021]
Phase 3 Trials of Tapinarof Cream for Plaque Psoriasis. [2021]
Dermal Safety of Tapinarof Cream 1%: Results From 4 Phase 1 Trials. [2022]
Tapinarof for the treatment of psoriasis. [2023]
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