Clinical trial

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

Name

35663/8/22

Description

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.

Trial arms

Trial start

2022-10-15

Estimated PCD

2024-04-30

Trial end

2024-04-30

Status

Recruiting

Phase

Early phase I

Treatment

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

Arms:

Study group

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

Arms:

Control group

Size

Primary endpoint

Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-02-06

1 organization

2 products

3 indications

Organization

Al-Azhar University

Product

5-Florouracil Effervescent Mixture

Indication

Indication

Indication

Product