Effervescent powder treatment for vitiligo
Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
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 |
| Enrollment | 60 (estimated) |
| Ages | 10 Years to 70 Years |
| Sex | All |
| Sponsor | Al-Azhar University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05536856 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals aged over 10 with localized stable vitiligo lesions that have not changed for at least one year.
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.
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 performed: While this approach is innovative, similar studies using topical formulations for vitiligo have shown varying degrees of success, indicating potential but also uncertainty.
Eligibility criteria
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 this trial is running
Cairo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.