Trial Summary
What is the purpose of this trial?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.
Eligibility Criteria
This trial is for adults over 18 with a certain skin type (Fitzpatrick skin type 3 or higher) who have been diagnosed with psoriasis. They must be stable on other treatments like biologics for at least three months before the study starts. People without this diagnosis or those with pigmentary changes that could affect outcome assessment cannot participate.Inclusion Criteria
I am an adult with a medium to dark skin tone, diagnosed with psoriasis.
I have been on the same biologic treatment for at least 3 months.
Exclusion Criteria
I do not have psoriasis and my skin type is 3 or above.
You have skin changes that could make it hard to evaluate the study results.
Participant Groups
The study compares two psoriasis treatments: Betamethasone dipropionate, a strong steroid cream, and Tapinarof, which works by targeting inflammation pathways. Participants will randomly receive one treatment to see how each affects skin pigmentation after inflammation.
2Treatment groups
Active Control
Group I: Betamethasone dipropionate 0.05%Active Control1 Intervention
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.
Group II: TapinarofActive Control1 Intervention
The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Wake Forest University Health Sciences Department of DermatologyWinston-Salem, NC
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Who Is Running the Clinical Trial?
Wake Forest University Health SciencesLead Sponsor
Dermavant Sciences, Inc.Industry Sponsor