Crisaborole ointment compared with tacrolimus ointment for psoriasis in skin folds and genital areas
Compares two skin ointments for psoriasis in skin folds or genital areas in adults.
Key facts
- Who runs it
- Cairo University
- Where
- Cairo, EgyptSee the site
- Trial code
- Registry title
- Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis.
- Status
- Not yet recruiting
- Phase
- Phase 3
- People taking part
- 40 people, planned
- Started
- 25 Oct 2026
- Expected to end
- 10 Jan 2027
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Crisaborole 2% topical ointment
- tacrolimus ointment 0.1%
- Record updated
- 27 October 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with psoriasis in skin folds and/or the genital or anal area. It compares crisaborole 2% ointment with tacrolimus 0.1% ointment.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed psoriasis in skin folds and/or the anogenital area, diagnosed by a doctor and by dermoscopy. PASI below 10 and/or BSA below 10%. Target Lesion Severity Score (TLSS) of 3 or more.
- Earlier treatment
- Cannot have used phototherapy or any topical psoriasis treatment in the last 1 month. Cannot have used systemic psoriasis treatment in the last 3 months (conventional drugs or biologics), or 6 months for those previously on acitretin.
Main reasons for not taking part
- Widespread plaque psoriasis (BSA 10% or more and/or PASI 10 or more), erythrodermic or pustular psoriasis
- Psoriatic arthritis or other co-morbidities
- Pregnant or breastfeeding women
- Allergy to crisaborole or tacrolimus, or skin thinning, visible small blood vessels or stretch marks in the target area
- Fungal or bacterial infection in the target area, or immunosuppressive condition or treatment
The registry criteria, word for word
Show all 15 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- A documented history of hypersensitivity or severe cutaneous reactions to any component of the active study medications (crisaborole or tacrolimus)
- Generalized Plaque Psoriasis ≥ 10% BSA and /or PASI ≥ 10
- Erythrodermic and Pustular Psoriasis
- Associated PSA or Other Co-morbidities
- Pregnant and lactating females
- Pre-existing signs of skin atrophy, telangiectasia or striae in the target area
Where in Egypt
- Faculty of Medicine Cairo UniversityCairo, EgyptContact: Riham M Mohamed, MD, MSc., PhDNo longer taking part
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Crisaborole 2% ointmentTreatment being tested
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.
Treatment: Crisaborole 2% topical ointment
- Tacrolimus 0.1% ointmentExisting treatment, for comparison
Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the intertriginous and/or anogenital lesions for 6 weeks.
Treatment: tacrolimus ointment 0.1%
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Efficacy of Crisaborole 2% Ointment Versus Tacrolimus 0.1% Ointment in the Treatment of Intertriginous and/or Anogenital Psoriasis: A Prospective Randomized Controlled Study.
- Plain-language title
- Crisaborole ointment compared with tacrolimus ointment for psoriasis in skin folds and genital areasGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 27 October 2026