Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: a new effervescent mixture 5-florouracil formula, 5-Fluorouracil plain powder.
- Who it may be relevant to
- Registry conditions: Vitiligo, Topical Fluorouracil, Effervescent Mixture. Basic parameters: 10 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
Overview
A novel approach for 5-Fluorouracil delivery based on a solid effervescent formulation is proposed . 5-Fluorouracil is water soluble (\~50mg/ml) and therefore has been used for the development of novel topical formulations including nano and microparticles intended for skin targeting. After hydration 5-Fluorouracil could form a complex, a suspension or even be formulated to generate effervescence. In effervescent technology, gas bubbles occur from the liquid after chemical reaction between alkali salts and organic acids (mainly citric or tartaric. Due to liberation in CO2 gas, the dissolution of drug in water is enhanced. The aim of this study is the development and clinical evaluation of topical 5-florouracil effervescent powder formulation in the treatment of vitiligo.
Interventions
- Drug a new effervescent mixture 5-florouracil formula
30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university - Drug 5-Fluorouracil plain powder
30 patients will apply the 5-florouracil plain powder on the selected patch followed by 3 milliliters of water till complete dissolution of the powder
Primary outcome measures
- Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation [Time frame: 3 Months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Facualty of Pharmacy, Al Azhar University — Cairo
Identifiers
NCT: NCT05536856 · 35663/8/22