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

Primary Purpose

ICD10 Code L40.9 for Psoriasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Betamethasone dipropionate 0.05%
Tapinarof
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for ICD10 Code L40.9 for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wake Forest University Health Sciences Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Betamethasone dipropionate 0.05%

Tapinarof

Arm Description

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.

Outcomes

Primary Outcome Measures

Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
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
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
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

Secondary Outcome Measures

Full Information

First Posted
July 31, 2023
Last Updated
September 25, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Dermavant Sciences, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05981118
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Dermavant Sciences, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ICD10 Code L40.9 for Psoriasis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Betamethasone dipropionate 0.05%
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Tapinarof
Arm Type
Active Comparator
Arm Description
The tapinarof group will be treated with 1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Betamethasone dipropionate 0.05%
Intervention Description
0.05% cream group will be treated once daily on both legs until clear or up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Tapinarof
Intervention Description
1% tapinarof cream applied once daily to both legs until clear or up to 12 weeks
Primary Outcome Measure Information:
Title
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
Description
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
Time Frame
Baseline to week 1
Title
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
Description
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
Time Frame
Week 1 to week 4
Title
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
Description
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
Time Frame
Week 4 to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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