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

Conditions

• ICD10 Code L40.9 for Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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

Study Details

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.

Key Dates

Start date

Jul 15, 2024

Status verified

Dec 2025

Primary completion

Jul 31, 2026

Completion

Dec 31, 2026

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• 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.
• 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.

Primary Outcome Measure

Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [ Time Frame: Baseline to week 1 ]

Locations (1)

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