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

NCT07892339 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: MS-629-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if topical application of crisaborole 2% ointment can treat flexural and/or genital psoriasis in adult patients of both genders. It will also learn about the safety of crisaborole 2% ointment. The main questions it aims to answer is:

• Does crisaborole 2% ointment work effectively in flexural and/or genital psoriasis in adults?
• is crisaborole 2% ointment well tolerated in flexural and/or genital psoriasis in adults?
• Is crisaborole 2% ointment comparable to tacrolimus 0.1% ointment in terms of efficacy and safety in flexural and/or genital psoriasis in adults? Researchers will compare crisaborole 2% ointment to tacrolimus 0.1% ointment to see if crisaborole works as effective and is as well-tolerated. Participants will:
• apply topical crisaborole 2% ointment or tacrolimus 0.1% ointment twice daily for 6 weeks to plaques of flexural and/or genital psoriasis.
• Visit the clinic once every 2 weeks for checkups and photography.
• Keep a diary of their symptoms.

Conditions

Psoriasis; Psoriasis Genital

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• 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

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

Secondary Outcomes (4)

• Visual Analogue Scale (VAS) for Pain and Pruritus

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

• Patient Satisfaction Score

  At the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).

• Psoriasis Area and Severity Index (PASI)

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

• Dermatology Life Quality Index (DLQI)

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

Other Outcomes (1)

• Pigmentary Alterations

  At the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).

Study Arms (2)

Crisaborole 2% ointment

EXPERIMENTAL

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.

Drug: Crisaborole 2% topical ointment

Tacrolimus 0.1% ointment

ACTIVE COMPARATOR

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.

Drug: tacrolimus ointment 0.1%

Interventions

Crisaborole 2% topical ointment DRUG

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

Crisaborole 2% ointment

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

Tacrolimus 0.1% ointment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥18 years) of both genders.
• A confirmed clinical and dermoscopic diagnosis of intertriginous and/or anogenital psoriasis.
• PASI\<10% and /or BSA\<10%.
• Target Lesion Severity Score (TLSS) ≥ 3.

You may not qualify if:

• Generalized Plaque Psoriasis ≥ 10% BSA and /or PASI ≥ 10.
• Erythrodermic and Pustular Psoriasis.
• Associated PSA or Other Co-morbidities.
• Pregnant and lactating females.
• A documented history of hypersensitivity or severe cutaneous reactions to any component of the active study medications (crisaborole or tacrolimus).
• Pre-existing signs of skin atrophy, telangiectasia or striae in the target area.
• Clinical or mycological evidence of concurrent fungal or bacterial infection in the target area.
• Immunosuppressive conditions or concurrent immunosuppressive therapy
• Use of phototherapy within 1 month prior to enrollment.
• Use of any topical antipsoriatic therapies within 1 month prior to enrollment.
• Use of any systemic antipsoriatic therapies within 3 months for conventional systemic agents or biologics, extending to 6 months for patients previously on acitretin.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, Egypt

Location

Related Publications (8)

• Hashim PW, Chima M, Kim HJ, Bares J, Yao CJ, Singer G, Chen T, Genece J, Baum D, Kimmel GW, Nia JK, Gagliotti M, Lebwohl MG. Crisaborole 2% ointment for the treatment of intertriginous, anogenital, and facial psoriasis: A double-blind, randomized, vehicle-controlled trial. J Am Acad Dermatol. 2020 Feb;82(2):360-365. doi: 10.1016/j.jaad.2019.06.1288. Epub 2019 Jul 3.

  PMID: 31279028 BACKGROUND

• Dattola A, Silvestri M, Bennardo L, Del Duca E, Longo C, Bianchi L, Nistico S. Update of calcineurin inhibitors to treat inverse psoriasis: A systematic review. Dermatol Ther. 2018 Nov;31(6):e12728. doi: 10.1111/dth.12728. Epub 2018 Oct 8.

  PMID: 30295379 BACKGROUND

• Li H, Zuo J, Tang W. Phosphodiesterase-4 Inhibitors for the Treatment of Inflammatory Diseases. Front Pharmacol. 2018 Oct 17;9:1048. doi: 10.3389/fphar.2018.01048. eCollection 2018.

  PMID: 30386231 BACKGROUND

• Milakovic M, Gooderham MJ. Phosphodiesterase-4 Inhibition in Psoriasis. Psoriasis (Auckl). 2021 Mar 17;11:21-29. doi: 10.2147/PTT.S303634. eCollection 2021.

  PMID: 33763335 BACKGROUND

• Reynolds KA, Pithadia DJ, Lee EB, Wu JJ. Treatments for inverse psoriasis: a systematic review. J Dermatolog Treat. 2020 Dec;31(8):786-793. doi: 10.1080/09546634.2019.1620912. Epub 2019 May 31.

  PMID: 31100992 BACKGROUND

• Beck KM, Yang EJ, Sanchez IM, Liao W. Treatment of Genital Psoriasis: A Systematic Review. Dermatol Ther (Heidelb). 2018 Dec;8(4):509-525. doi: 10.1007/s13555-018-0257-y. Epub 2018 Aug 25.

  PMID: 30145740 BACKGROUND

• Yang EJ, Beck KM, Sanchez IM, Koo J, Liao W. The impact of genital psoriasis on quality of life: a systematic review. Psoriasis (Auckl). 2018 Aug 28;8:41-47. doi: 10.2147/PTT.S169389. eCollection 2018.

  PMID: 30214891 BACKGROUND

• Dopytalska K, Sobolewski P, Blaszczak A, Szymanska E, Walecka I. Psoriasis in special localizations. Reumatologia. 2018;56(6):392-398. doi: 10.5114/reum.2018.80718. Epub 2018 Dec 23.

  PMID: 30647487 BACKGROUND

MeSH Terms

Conditions

Psoriasis

Interventions

crisaborole; Ointments

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Riham M Mohamed, MD, MSc., PhD

CONTACT

+201066239360; riham.mohye@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: A prospective randomized comparative controlled study

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start (Estimated): October 25, 2026
• Primary Completion (Estimated): December 13, 2026
• Study Completion (Estimated): January 10, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)