Clinical trial

Efficacy of Topical 5-fluorouracil Versus Topical Latanoprost With Microneedling in Localized Stable Vitiligo: A Randomised Clinical Trial

Name
370
Description
This study aims to compare the efficacy of topical 5-fluorouracil versus topical latanoprost after skin microneedling in the induction of skin repigmentation in localized stable vitiligo patients.
Trial arms
Trial start
2022-03-15
Estimated PCD
2022-11-01
Trial end
2022-12-01
Status
Completed
Phase
Early phase I
Treatment
Latanoprost 0.005% Ophthalmic Solution
The affected area cleaned with betadine surgical solution followed by alcohol 70%. Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure. Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears. The LT solution will be applied immediately to vitiligo patch one drop (contains 1.5 μg of LT) for every 2.5 cm. This procedure will be repeated every two weeks for six months.
Arms:
Group A (topical latanoprost)
Other names:
Microneedling using Dr Pen Derma Pen Ultima A6®
5Fluorouracil
The affected area cleaned with betadine surgical solution followed by alcohol 70%. Local anesthetic, pridocaine cream, applied on the treated area under occlusion for 30 min before the procedure. Using automated microneedling device (Dr Pen Derma Pen Ultima A6®) , which has a disposable head that personalized for each patient and sterilized after each session. The derma pen will penetrate the skin with variable depths ranging from 0.25 to 0.5 mm (not more than the depth of the epidermis). It will pass vertically over the vitiligo area in a circular pattern until pinpoint bleeding appears. Topical application of 5-fluorouracil 5% solution will be rubbed over the affected area for about 2 minutes. Occlusive dressing for hours. This procedure will be repeated every two weeks for six months.
Arms:
Group B (topical 5-fluorouracil)
Other names:
Microneedling using Dr Pen Derma Pen Ultima A6®
Size
40
Primary endpoint
Assessment of clinical repigmentation changes of vitiligo lesions according to Physician's Global Assessment [PGA]
6 months
Eligibility criteria
Inclusion Criteria: * Patients of both sexes with stable localized vitiligo : patches should not have any increase or decrease in size or pigmentation for at least 3 months. Exclusion Criteria: * Pregnant or lactating female. * Active Koebner's phenomenon. * Age less than 10 years. * All patients included had not received any local or systemic medication for at least 2 months before the study. * Keloidal tendency.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2023-07-11

1 organization

2 products

1 indication

Indication
Vitiligo