Effervescent powder treatment for vitiligo
Official title: Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
Run by Al-Azhar University · NCT05536856 · Data updated 2026-11-12
This study is testing a new effervescent powder treatment for stable vitiligo to see if it works better than regular powder in helping people with skin discoloration.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 10 Years to 70 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | October 15, 2022 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | January 6, 2026 |
| Trial ID | NCT05536856 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged over 10 with localized stable vitiligo lesions that have not changed for at least one year.
✕Probably not a fit
Patients with vitiligo patches on mucous membranes or those who have received recent treatments for vitiligo may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates a novel effervescent formulation of 5-Fluorouracil for the treatment of localized stable vitiligo. The study aims to enhance the delivery of the drug through a unique effervescent mixture that improves solubility and absorption. Participants will receive either the new effervescent powder or plain 5-Fluorouracil powder to assess the effectiveness of this innovative approach. The trial will include patients aged over 10 years with stable vitiligo lesions for at least one year.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective option for patients with vitiligo, potentially improving skin repigmentation.
How similar studies have gone: While this approach is innovative, similar studies using topical formulations for vitiligo have shown varying degrees of success, indicating potential but also uncertainty.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who will be diagnosed as localized stable vitiligo. * Age older than 10 years * Stability of lesions for a duration of at least 1 year. * Patients who didn't receive treatment for vitiligo in the previous 6 weeks before starting the study. * Patients who agreed to join the study and signed written consent and continued till the end of the follow up period Exclusion Criteria: * Patients with vitiligo patches on mucous membrane, * Patients with Koebner phenomenon, * Other uncontrolled systemic illnesses * Patients receiving any systemic or topical treatment for vitiligo
Where it's running
-
Facualty of Pharmacy, Al Azhar University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Neveen A. Kohaf, Ph.D
- Email: nevenabdo@azhar.edu.eg
- Phone: +201069482380
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
crisaborole 2% versus tacrolimus 0.1% with light therapy for facial vitiligo
This study tests whether applying crisaborole 2% ointment can improve stable facial vitiligo in children and adults and whether it is as safe and effective as tacrolimus 0.1% when combined with light therapy.
-
Imaging vitiligo lesions with polarized, sub-ultraviolet, and ultraviolet dermoscopy
This study tests whether advanced light-based skin imaging can reveal details of vitiligo spots in adults more clearly than standard polarized dermoscopy.
-
MH004 Ointment in non-segmental vitiligo: a phase 3 trial
A 12-month randomized trial tests MH004 ointment to see if it helps facial vitiligo more than a placebo in people aged 12 to 75.
-
NSV: Vitiligo Drug Safety and Effectiveness Registry for Adults and Teens
This registry tracks adults and teens with nonsegmental vitiligo to see how usual treatments work and how safe they are over time in real-world dermatology care.
-
D-2570 in Non-Segmental Vitiligo (Phase 2)
This study tests whether D-2570 can improve skin discoloration in adults with non-segmental vitiligo compared with a placebo.
-
LY4005130 for adults with non-segmental vitiligo
This study will test whether intravenous LY4005130 is safe and what side effects it may cause in adults with non-segmental vitiligo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.