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

Overview

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.

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

Primary outcome measures

• Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [Time frame: Baseline to week 1]
• Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [Time frame: Week 1 to week 4]
• Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [Time frame: Week 4 to week 12]

Eligibility criteria

Inclusion criteria

• 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.
• Stable on other therapies such as biologics for at least 3 months before randomization.

Exclusion criteria

• Lack of a diagnosis of psoriasis (ICD10 code L40.9) or Fitzpatrick skin type below 3.
• Pigmentary changes that in the opinion of the investigator would compromise the ability to assess the study outcomes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Wake Forest University Health Sciences Department of Dermatology — Winston-Salem

Identifiers

NCT: NCT05981118 · IRB00099131

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗