Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Al-Azhar University

Status and phase: Enrolling; Phase 4

Conditions: Topical Fluorouracil; Vitiligo; Effervescent Mixture

Treatments: Drug: a new effervescent mixture 5-florouracil formula; Drug: 5-Fluorouracil plain powder

Study type: Interventional

Funder types: Other

Identifiers

NCT05536856

35663/8/22

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 10 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Control group

Experimental group

Description:

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.

Treatment:

Drug: 5-Fluorouracil plain powder

Study group

Experimental group

Description:

30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university

Treatment:

Drug: a new effervescent mixture 5-florouracil formula