Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo

Sponsor

Al-Azhar University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05536856

Collaborator

(none)

Enrollment

Location

Arms

5.9

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vitiligo Topical Fluorouracil Effervescent Mixture	Drug: a new effervescent mixture 5-florouracil formula Drug: 5-Fluorouracil plain powder	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 15, 2022

Anticipated Primary Completion Date :

Mar 15, 2023

Anticipated Study Completion Date :

Mar 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Control group 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 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
Experimental: Study group 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 30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university

Arm

Intervention/Treatment

Experimental: Control group

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

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

Experimental: Study group

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

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

Outcome Measures

Primary Outcome Measures

Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation [3 Months]
repigmentation assessment

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Facualty of Pharmacy, Al Azhar University	Cairo		Egypt	11765

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT05536856

Other Study ID Numbers:

35663/8/22

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Neveen Abd El Maksoad Kohaf, Lecturer of Clinical Pharmacy, Al-Azhar University

Vitiligo

Fluorouracil

Effervescent powder

Additional relevant MeSH terms:

Vitiligo

Fluorouracil

Study Results

No Results Posted as of Sep 13, 2022