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Corticosteroid
Betamethasone vs. Tapinarof for Psoriasis
N/A
Waitlist Available
Led By Steven R Feldman, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 4 to week 12
Awards & highlights
Study Summary
This trial will study how two psoriasis treatments affect the post-inflammatory pigmentation of legs. Photos, scales, and patient symptoms will be used to measure outcomes.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include changes in skin coloration, irritation at the application site such as redness, burning sensation, peeling of the skin, and dryness. The severity of these side effects will vary among individuals.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with a medium to dark skin tone, diagnosed with psoriasis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 4 to week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 4 to week 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Examine the degree of Post-inflammatory pigment alteration (PIPA) in both intervention Arms
Trial Design
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.
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,143 Total Patients Enrolled
12 Trials studying Psoriasis
963 Patients Enrolled for Psoriasis
Dermavant Sciences, Inc.Industry Sponsor
5 Previous Clinical Trials
1,162 Total Patients Enrolled
3 Trials studying Psoriasis
165 Patients Enrolled for Psoriasis
Steven R Feldman, MD, PhDPrincipal InvestigatorWake Forest University Health Sciences
14 Previous Clinical Trials
563 Total Patients Enrolled
4 Trials studying Psoriasis
171 Patients Enrolled for Psoriasis
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.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.
Research Study Groups:
This trial has the following groups:- Group 1: Betamethasone dipropionate 0.05%
- Group 2: Tapinarof
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities for individuals to join this research program?
"Per the information hosted on clinicaltrials.gov, currently this trial is not recruiting participants. The research was initially posted in September 1st 2023 and last updated July 31st 2023; despite that, there are 164 other medical studies actively looking for volunteers."
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