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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05981118

Collaborator

Dermavant Sciences, Inc. (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ICD10 Code L40.9 for Psoriasis	Drug: Betamethasone dipropionate 0.05% Drug: Tapinarof	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Betamethasone dipropionate 0.05% 0.05% cream group will be treated 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.	Drug: Tapinarof 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks

Arm

Intervention/Treatment

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.

Drug: Betamethasone dipropionate 0.05%

0.05% cream group will be treated 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.

Drug: Tapinarof

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

Outcome Measures

Primary Outcome Measures

Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [Baseline to week 1]
Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [Week 1 to week 4]
Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms [Week 4 to week 12]
Details regarding the area of pigmentation changes, intensity of hyper- or hypopigmentation, erythema, burning, and dryness will be assessed. PIPA will be assessed using the Taylor Pigmentation Scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.