Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Study Overview
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Brief Summary
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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.

Official Title
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Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo

Conditions
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Vitiligo, Topical Fluorouracil, Effervescent Mixture

Intervention / Treatment
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* Drug: a new effervescent mixture 5-florouracil formula
* Drug: 5-Fluorouracil plain powder


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>30 patients will apply the 5-Fluorouracil plain powder on the selected patch followed by 3 milliliters of water till complete dissolution of the powder. | Drug: 5-Fluorouracil plain powder<br>* 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<br>|
| Experimental: Study group<br>30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university | Drug: a new effervescent mixture 5-florouracil formula<br>* 30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation | repigmentation assessment | 3 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitiligo, Fluorouracil, Effervescent powder