A Phase 3 interventional study of Crisaborole 2% topical ointment and tacrolimus ointment 0.1% in Psoriasis and Psoriasis Genital, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Cairo University · Phase 3, Interventional, and Treatment
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:
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:
The proposed study is a prospective, open-label randomized clinical study that will enrolled adult patients with intertriginous and/or anogenital psoriasis who will be recruited from KAPU (Kasr Al-Ainy Psoriasis Unit), Dermatology outpatient clinic, Dermatology department, Kasr AlAiny hospitals, Cairo University. The study aims to assess the efficacy, safety and tolerability of crisaborole 2% ointment in the treatment of intertriginous and/or anogenital psoriasis in comparison to tacrolimus 0.1% ointment in adults.
1,928 studies on the registry are indexed under Psoriasis; 234 are open to participants now.
This study's planned enrollment of 40 is below the median of 70 across 1,472 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →Cairo University is the lead sponsor of 4,907 studies on the registry; 1,445 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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%
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
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
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.
Time frame: 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.
Time frame: 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
Time frame: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).
Visual Analogue Scale (VAS) for Pain and Pruritus
Subjective localized symptoms, including pain, burning, and itching, will be assessed using a standardized VAS.
Time frame: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).
Patient Satisfaction Score
Subjective overall satisfaction with the assigned topical therapy will be recorded from 0 (unsatisfied) to 10 (completely satisfied) via a standardized scale.
Time frame: At the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).
Psoriasis Area and Severity Index (PASI)
The PASI is the most widely used clinician-rated instrument for assessing the severity and extent of psoriasis. It combines the evaluation of lesion severity and the percentage of affected body surface area into a single composite score. The body is divided into four regions: head (10%), upper limbs (20%), trunk (30%), and lower limbs (40%). For each region, three clinical signs of psoriasis-erythema (redness), induration (thickness), and desquamation (scaling)-are rated on a 5-point scale from 0 (none) to 4 (severe); The area affected in each region is scored from 0 (0%) to 6 (90-100%). Regional scores are then weighted and summed to produce a total PASI score ranging from 0 to 72, with higher scores indicating greater disease severity.
Time frame: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).
Dermatology Life Quality Index (DLQI)
Validated Arabic translation will be used. DLQI is a validated questionnaire which grades QoL by assessing the following domains: (a) physical symptoms and feelings (questions 1 and 2), (b) daily activities (questions 3 and 4), (c) leisure (questions 5 and 6), (d) work/school (questions 7), (e) personal relationships (questions 8 and 9), and (f) treatment (question 10). Each question is scored as "very much" (score 3), "a lot" (score 2), "a little" (score 1), and "not at all" (score 0), keeping in mind the problems faced the previous week due to the disease. Final DLQI score is the sum of all scores (range 0-30). High scores indicate poor QoL.
Time frame: From enrollment to the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).
Pigmentary Alterations
Detailed comparative assessments tracking the emergence of post-inflammatory hyperpigmentation or hypopigmentation within the target areas will be carried out across both cohorts.
Time frame: At the end of treatment at 6 weeks and at 10 weeks (4 weeks after treatment cessation).
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Crisaborole