Effervescent Mixture, Topical Fluorouracil, Vitiligo
Conditions
Keywords
Vitiligo, Fluorouracil, Effervescent powder
Brief summary
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
DRUGa 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
DRUG5-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
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation | 3 Months | repigmentation assessment |
Countries
Egypt
Contacts
Primary ContactNeveen A. Kohaf, Ph.D
Outcome results
None listed