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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 16 (visit 4)

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

Nasopharyngitis

Dermatitis contact

Headache

Pruritus

Viral upper respiratory tract infection

Back pain

Cough

abdominal pain

Upper respiratory tract infection

Influenza

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Tapinarof (DMVT-505)

Vehicle Cream

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met