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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: ICD10 Code L40.9 for Psoriasis
• Intervention / Treatment: Drug: Betamethasone dipropionate 0.05%; Drug: Tapinarof

Detailed Description

Subjects will be randomized to either of the two treatment groups (betamethasone dipropionate or tapinarof) and will be treated with that medication for until clear or up to 12 weeks . Photographs will be taken before and after treatment. 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. The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.

Subjects will return every 4 weeks for evaluation. If disease recurs after clearing, treatment will be re-instituted.

Both groups will also be followed up at 1 and 4 weeks after end of treatment to monitor for PIPA and any other after-treatment effects.

Healthcare providers and patients may benefit from the information obtained during this study; study subjects may directly benefit from participation as they will be treated with standard treatments for psoriasis. We hope the information gathered will help healthcare providers better serve patients and identify psoriasis treatment after-effects.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Stable on other therapies such as biologics for at least 3 months before randomization.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Betamethasone dipropionate 0.05%; 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%; 0.05% cream group will be treated once daily on both legs until clear or up to 12 weeks
Active Comparator: Tapinarof; 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; 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Dermavant Sciences, Inc.
• Investigators: Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 17, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis; Pigmentation Disorders; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Respiratory System Agents; Anti-Asthmatic Agents; tapinarof
• Other Study ID Numbers: IRB00099131

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No