A Phase 3 interventional study of Crisaborole 2% topical ointment and tacrolimus 0.1% in Vitiligo, Non-Segmental Vitiligo (NSV) and Stable Vitiligo, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.
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 stable patches of facial vitiligo in pediatrics and 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, assessor-blinded, randomized clinical study that enrolls pediatric and adult patients with stable localized facial vitiligo who are recruited from Kasr Al-Ainy vitiligo 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 stable localized facial vitiligo in comparison to tacrolimus 0.1% ointment in pediatrics and adults.
343 studies on the registry are indexed under Vitiligo; 96 are open to participants now.
This study's planned enrollment of 35 is close to the median of 36 across 265 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 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.
Stable vitiligo defined by fulfillment of both of the following criteria simultaneously at screening:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the facial vitiligo lesions and undergo Excimer light sessions twice weekly for 6 months (or until complete repigmentation, whichever earlier).
Drug: Crisaborole 2% topical ointment · Device: Excimer Light therapy
Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the facial vitiligo lesions and undergo Excimer light sessions twice weekly for 6 months (or until complete repigmentation, whichever earlier)
Drug: tacrolimus 0.1% · Device: Excimer Light therapy
Participants will be instructed to apply a thin layer of Crisaborole 2% ointment twice daily to the facial vitiligo patches.
Participants will be instructed to apply a thin layer of Tacrolimus 0.1% ointment twice daily to the facial vitiligo patches.
Participants will undergo Excimer light sessions twice weekly to the facial vitiligo patches.
Also known as: XECL-308D
Facial Vitiligo Area Scoring Index (F-VASI)
The F-VASI is used specifically to quantify facial vitiligo involvement. The F-VASI score is calculated by multiplying the percentage of affected facial surface area by the degree of depigmentation for each facial site and summing these values across all facial sites. The F-VASI score ranged from 0 to 3, with lower scores indicating greater clinical improvement.
Time frame: Upon enrollment, at 12 weeks and at 24 weeks
Vitiligo Extent Score for a Target Area (VESTA)
The score consists of: 1. Reference images for marginal repigmentation. 2. Reference images for perifollicular repigmentation. 3. A formula for calculating total repigmentation percentage. Total repigmentation percentage was defined as the sum of the fully repigmented area and perifollicular repigmentation in the remaining depigmented area.
Time frame: At 12 weeks and at 24 weeks
Time to onset of repigmentation
Time to onset of repigmentation is recorded.
Time frame: Since enrollment and throughout the treatment period till completion of the study
Vitiligo Impact Scale-22 (VIS-22)
Health-related quality of life is assessed using the Vitiligo Impact Scale-22 (VIS-22), a validated vitiligo-specific questionnaire composed of 22 items evaluating multiple psychosocial domains including anxiety, depression, self-confidence, social interactions, occupation, family relationships, and treatment-related concerns. The total score ranges from 0 to 66, with higher scores indicating greater impairment in quality of life.
Time frame: At 12 weeks and at 24 weeks
Patient Satisfaction
Patient satisfaction was assessed using a standardized five-point Likert scale as follows: 1. Very dissatisfied. 2. Dissatisfied. 3. Neutral. 4. Satisfied. 5. Very satisfied.
Time frame: At 12 weeks and at 24 weeks
Plan to share: No
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Of 18 phase 3 interventional studies under Vitiligo, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 25 and three quarters within 44. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
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 ↗
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Studies of the drug tested here: Crisaborole