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Anti-inflammatory

Tapinarof for Palmoplantar Keratoderma

Phase 2
Recruiting
Led By David Rosmarin, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female subjects in their adult years (≥ 18 years of age), inclusive, from the time of providing written subject-investigator agreement
Confirmed clinical diagnosis of palmoplantar keratoderma
Must not have
Treatment with topical corticosteroids during the duration of the study
Treatment with keratolytic agents (eg, 6% salicylic acid, 70% propylene glycol, 30% water) during the duration of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 16 (visit 4)
Awards & highlights

Summary

"This trial aims to see how effective and safe tapinarof, a natural compound used for treating psoriasis, is in treating palmoplantar keratoderma. The study will investigate the benefits of

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While specific side effects are not detailed here, similar treatments often cause skin irritation or reactions at the application site. Systemic side effects are less common but may include issues related to absorption through the skin.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with palmoplantar keratoderma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I will use topical corticosteroids during the study.
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I am not using skin treatments like salicylic acid during the study.
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I will use topical retinoids throughout the study.
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I will use vitamin D ointment as part of the study.
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I will be taking acitretin during the study.
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I have been treated with Tapinarof before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 16 (visit 4)
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 16 (visit 4) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Physician's Global Assessment (PGA)
Secondary study objectives
Dermatology Life Quality Index (DLQI)
Patient Global Assessment (PtGA)
Skin assessment every visit
+2 more

Side effects data

From 2020 Phase 3 trial • 510 Patients • NCT03956355
23%
Folliculitis
7%
Nasopharyngitis
4%
Dermatitis contact
3%
Headache
2%
Pruritus
2%
Viral upper respiratory tract infection
1%
Back pain
1%
Cough
1%
abdominal pain
1%
Upper respiratory tract infection
1%
Influenza
1%
Rash
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tapinarof (DMVT-505)
Vehicle Cream

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tapinarof
2023
Completed Phase 4
~1060

Find a Location

Who is running the clinical trial?

Dermavant Sciences, Inc.Industry Sponsor
8 Previous Clinical Trials
2,015 Total Patients Enrolled
Indiana UniversityLead Sponsor
1,019 Previous Clinical Trials
1,114,209 Total Patients Enrolled
David Rosmarin, MDPrincipal InvestigatorDermatology
5 Previous Clinical Trials
46 Total Patients Enrolled
~4 spots leftby Feb 2026
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