Back to resultsTopical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
Primary Purpose
Vitiligo, Topical Fluorouracil, Effervescent Mixture
Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
a new effervescent mixture 5-florouracil formula
5-Fluorouracil plain powder
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Fluorouracil, Effervescent powder
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
Sites / Locations
- Facualty of Pharmacy, Al Azhar UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Control group
Study group
Arm 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.
30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university
Outcomes
Primary Outcome Measures
Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation
repigmentation assessment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05536856
Brief Title
Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
Official Title
Development and Clinical Evaluation of Topical 5-Fluorouracil Effervescent Powder Formulation in the Treatment of Vitiligo
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
November 15, 2023 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo, Topical Fluorouracil, Effervescent Mixture
Keywords
Vitiligo, Fluorouracil, Effervescent powder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Experimental
Arm 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.
Arm Title
Study group
Arm Type
Experimental
Arm Description
30 patients will apply a new effervescent mixture formula of 5-Fluorouracil prepared at faculty of pharmacy (Girls) - Al-Azhar university
Intervention Type
Drug
Intervention Name(s)
a new effervescent mixture 5-florouracil formula
Intervention Description
30 patients will apply a new effervescent mixture 5-florouracil formula prepared at faculty of pharmacy (Girls) - Al-Azhar university
Intervention Type
Drug
Intervention Name(s)
5-Fluorouracil plain powder
Intervention Description
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
Primary Outcome Measure Information:
Title
Vitiligo Area Scoring Index ranged from -50 for very much worse to +50 for very much improved. Improvement means repigmentation
Description
repigmentation assessment
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neveen A. Kohaf, Ph.D
Phone
+201069482380
Email
nevenabdo@azhar.edu.eg
Facility Information:
Facility Name
Facualty of Pharmacy, Al Azhar University
City
Cairo
ZIP/Postal Code
11765
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neveen A. Kohaf, Ph.D
Phone
+201069482380
Email
nevenabdo@azhar.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data can be shared with a reasonable request from the corresponding author
Learn more about this trial
Topical 5-Fluorouracil Effervescent Powder in the Treatment of Vitiligo
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