crisaborole 2% versus tacrolimus 0.1% with light therapy for facial vitiligo

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, assessor-blinded, randomized phase 3 trial comparing crisaborole 2% ointment to tacrolimus 0.1% ointment, each used twice daily for up to 6 months, with the option of complete repigmentation. Participants have stable, localized facial vitiligo and are aged 6 years or older, recruited from Kasr Al-Ainy at Cairo University. The study also incorporates excimer light therapy as part of the treatment approach and aims to evaluate efficacy, safety, and tolerability in pediatrics and adults. Key outcomes include repigmentation and adverse events to determine if crisaborole can be a viable alternative to tacrolimus for facial vitiligo.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 6 years old.
* Both male and female patients.
* Localized facial vitiligo involving less than 50% of the facial surface area.
* Stable vitiligo defined by fulfillment of both of the following criteria simultaneously at screening:

  * Vitiligo Disease Activity (VIDA) score ≤ 0.
  * Vitiligo Signs of Activity Score (VSAS) = 0.
* Ability and willingness to comply with treatment and follow-up visits

Exclusion Criteria:

* Patients younger than 6 years.
* Segmental vitiligo.
* Vitiligo universalis.
* Pregnancy \& breastfeeding.
* History of transplantation procedure for vitiligo within the past 6 months.
* History of hypersensitivity to the study medication.
* History of any skin bleaching treatment for vitiligo or other dermatoses at any point.
* Any contraindication to excimer light therapy e.g., history of skin cancer, photosensitivity disorders.
* Current history of systemic therapy or phototherapy.
* Any topical treatment (such as topical steroids, calcineurin inhibitors, vitamin D analogs, JAK inhibitors, PDE4i) requires a washout period of 2 weeks before screening visit and through the final safety follow-up visit.
* Ultraviolet light exposure, including UVB/UVA/PUVA delivered by booth/excimer laser, or tanning bed exposure, requires a washout period of 8 weeks before screening and through the final safety follow-up visit.

Where it's running

• Faculty of Medicine, Cairo University
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Riham M Mohamed, MD, MSc., PhD
• Email: riham.mohye@cu.edu.eg
• Phone: +201066239360

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.