Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 years and older
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Psoriasis, Psoriasis Genital

Being tested

Crisaborole 2% topical ointment, tacrolimus ointment 0.1%

Keywords

psoriasis, genital psoriasis, flexural psoriasis, anogenital psoriasis, intertriginous psoriasis, crisaborole, tacrolimus, TLSS, PASI

Medical subject headings

Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Crisaborole 2% topical ointmentDrug

  Participants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the affected intertriginous and/or anogenital lesions for 6 weeks. The amount to be applied will be guided by the fingertip unit (FTU), with approximately 1 FTU considered sufficient to cover 2% of adult body surface area (BSA), corresponding roughly to the area of two adult palms

• tacrolimus ointment 0.1%Drug

  Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the affected intertriginous and/or anogenital lesions for 6 weeks. The amount to be applied will be guided by the fingertip unit (FTU), with approximately 1 FTU considered sufficient to cover 2% of adult body surface area (BSA), corresponding roughly to the area of two adult palms

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Target Lesion Severity Score (TLSS)

   The TLSS will be used to assess the clinical severity of a representative psoriatic lesion during the study period. This score is commonly employed in clinical trials evaluating topical therapies for localized psoriasis because it allows detailed assessment of changes within a selected target plaque over time.

   The TLSS evaluates three principal clinical signs of psoriasis: erythema, scaling, and plaque elevation/induration. Each parameter is graded separately on a 5-point scale ranging from 0 to 4, where 0 indicates absence of the sign, 1 indicates mild involvement, 2 moderate involvement, 3 marked involvement, and 4 very marked or severe involvement. The total TLSS is calculated by summing the individual scores, resulting in a total score ranging from 0 to 12, with higher scores reflecting greater lesion severity.

   Measured: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).

2. Static Physician's Global Assessment (sPGA)

   The sPGA is a validated investigator-based assessment tool that rates disease severity at a single point in time based on plaque characteristics including erythema, scaling, and induration. Scores are typically graded on a 5-point scale ranging from 0 (clear) to 4 (severe disease).

   The static Physician's Global Assessment (sPGA) will be used to evaluate the overall clinical severity of psoriasis lesions throughout the study.

   Measured: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).

3. Dynamic Physician Global Assessment (dPGA)

   Dynamic PGA provides a global assessment of the change in psoriasis severity between baseline and the end of treatment. The change will be assessed by comparing standardized clinical photographs that will be obtained at baseline with those that will be obtained at week 6 by a blinded investigator.

   The dynamic PGA will be scored on an 11-point scale ranging from -5 to +5, with positive scores indicating improvement, zero indicating no meaningful change, and negative scores indicating deterioration

   Measured: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted23 Oct 2026
2. Study start25 Oct 2026 (estimated)
3. Primary completion13 Dec 2026 (estimated)
4. Study completion10 Jan 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (8)Papers the sponsor has linked to this study.
• Other trials for PsoriasisStudies of the same condition, open and under way.
• More trials run by Cairo UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.