Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

• Status: Not yet recruiting
• Trial end date: 2023-03-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Al-Azhar University
• Treatments: Fluorouracil

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