By InvitationPhase 2/3

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

United States40 participantsStarted 2024-07-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to week 1

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

Timeframe: Week 1 to week 4

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

Timeframe: Week 4 to week 12

Trial details

NCT IDNCT05981118

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

View on ClinicalTrials.gov More ICD10 Code L40.9 for Psoriasis trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline to week 1

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

Timeframe: Week 1 to week 4

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

Timeframe: Week 4 to week 12