Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age10-70
SponsorAl-Azhar University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Design model
Parallel
Treatments tested in this trial
a new effervescent mixture 5-florouracil formula
Drug30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university
5-Fluorouracil plain powder
Drug30 patients will apply the 5-florouracil plain powder on the selected patch followed by 3 milliliters of water till complete dissolution of the powder
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Control groupExperimental treatment 1 intervention
Group B: Study groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation
repigmentation assessment
Time frame
3 MonthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov