drugset / Trial / NCT05981118

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

NCT05981118

Phase 2/3 Enrolling by invitation 40 enrolled Wake Forest University Health Sciences Dermavant Sciences GmbH · collab
RandomizedParallel-groupOpen-labelHealth-services research

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.

Timeline

Start
2024-07-15
Primary completion
2026-07
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Tapinarof Other / unclassified 1 % Topical
Comparator betamethasone dipropionate Small molecule 0.05 % Topical

Indications

No indication recorded.