Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)

NCT05981118 | Enrolling By Invitation Phase 2 FDA Drug

• 1 other identifier: IRB00099131
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective study is to evaluate the degree of post-inflammatory pigmentation alteration on legs of study subjects treated with two different psoriasis treatments. Betamethasone dipropionate 0.05% cream is a high potency steroid that is commonly used to alleviate the inflammation of psoriasis. Tapinarof is another medication approved for psoriasis; tapinarof activates aryl hydrocarbon receptors to downregulate inflammatory cytokines (such as interleukin \[IL\]-17) which play a large role in psoriasis. Study subjects will be randomized to receive one of these medications and will be followed to monitor for PIPA. Photographs will be taken to help evaluate visual changes. The Taylor Hyperpigmentation scale will be used to grade the area and severity of hyperpigmentation and hypopigmentation; severity of erythema, burning, peeling, and dryness will also be recorded. This will allow us to understand the effects of two standard-of-care psoriasis medications to better treat patients.

Conditions

ICD10 Code L40.9 for Psoriasis

Outcome Measures

Primary Outcomes (3)

• Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms

  Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale

  Baseline to week 1

• Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms

  Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale

  Week 1 to week 4

• Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms

  Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale

  Week 4 to week 12

Study Arms (2)

Betamethasone dipropionate 0.05%

ACTIVE COMPARATOR

The betamethasone dipropionate 0.05% cream group will be treated with betamethasone dipropionate 0.05% cream once daily on both legs until clear or up to 12 weeks.

Drug: Betamethasone dipropionate 0.05%

Tapinarof

ACTIVE COMPARATOR

The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.

Drug: Tapinarof

Interventions

Betamethasone dipropionate 0.05% DRUG

0.05% cream group will be treated once daily on both legs until clear or up to 12 weeks

Betamethasone dipropionate 0.05%

Tapinarof DRUG

1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks

Tapinarof

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age 18+) with Fitzpatrick skin type 3 or higher who have been diagnosed with ICD10 code L40.9 for psoriasis between \[dates\] at Atrium Health Wake Forest Baptist Medical Center.
• Stable on other therapies such as biologics for at least 3 months before randomization.

You may not qualify if:

• Lack of a diagnosis of psoriasis (ICD10 code L40.9) or Fitzpatrick skin type below 3.
• Pigmentary changes that in the opinion of the investigator would compromise the ability to assess the study outcomes.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Dermavant Sciences, Inc.: collaborator

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Interventions

tapinarof

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)