Clinical trial NCT05981118: Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)
Official title: Comparison of Post-Inflammatory Pigment Alteration After Psoriasis Treatment (PIPA - Dermavant)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: ICD10 Code L40.9 for Psoriasis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Dermavant Sciences, Inc.
First posted: 2023-08-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
timeFrame: Baseline to week 1
measure: Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
timeFrame: Week 1 to week 4
measure: Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
timeFrame: Week 4 to week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: