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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05981118
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Steven R Feldman, MD, PhD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 ICD10 Code L40.9 for Psoriasis
Additional Details

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.

Arms & Interventions

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.

Interventions

Drug: - Betamethasone dipropionate 0.05%

0.05% cream group will be treated once daily on 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

Contact a Trial Team

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Winston-Salem, North Carolina

Status

Address

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157

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