Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202508513182931 Date of Registration: 11/08/2025
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Efficacy of Trichloroacetic Acid 70% After Microneedling versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Non-segmental Vitiligo: Comparative study
Official scientific title Efficacy of Trichloroacetic Acid 70% After Microneedling versus Intralesional Triamcinolone Acetonide Injection in the Treatment of Non-segmental Vitiligo: Comparative study
Brief summary describing the background and objectives of the trial Background: Vitiligo represents a chronic dermatological disorder manifested by depigmented skin areas resulting from melanocyte dysfunction. The etiology remains multifactorial, encompassing autoimmune mechanisms, hereditary predisposition, and environmental triggers. This condition profoundly impacts psychological well-being, contributing to emotional distress, diminished self-confidence, and social isolation. Aim of the study: A comparative study was conducted to evaluate the efficacy of Trichloroacetic Acid 70% after microneedling versus intralesional Triamcinolone Acetonide injection in the treatment of non-segmental vitiligo
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Skin and Connective Tissue Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/01/2024
Actual trial start date 01/01/2024
Anticipated date of last follow up 06/12/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group TA Group Both treatment modalities were administered at bi-weekly intervals. The treatment course continued until complete repigmentation was achieved or for a maximum of six sessions. In this arm, a designated vitiligo patch on each of the 30 patients was treated with intralesional injections of Triamcinolone Acetonide (Epirelefan® 40 mg/2ml vial). The drug was diluted with normal saline to a final concentration of 5 mg/mL (a 1:7 dilution) under aseptic conditions. Following the application of a topical anesthetic cream (Pridocaine® 15gm cream) under occlusion for 30 minutes, the diluted solution was administered via intradermal injection. Injections were spaced at 1 cm intervals, with a volume of 0.01 to 0.02 mL delivered per site using a 30-gauge insulin syringe, adhering to strict aseptic precautions. 30 Active-Treatment of Control Group
Experimental Group TCA after microneedling group Both treatment modalities were administered at bi-weekly intervals. The treatment course continued until complete repigmentation was achieved or for a maximum of six sessions. a comparable contralateral or adjacent patch on the same 30 patients was treated with a combination of microneedling followed by the application of 70% Trichloroacetic Acid. After local anesthesia as described for Group A, microneedling was performed with an automated device (Dr.pen A6 version) fitted with a disposable 36microneedle titanium cartridge. The procedure was executed at the device's lowest speed setting, with needle penetration depth adjusted from 0.5 to 2.0 mm according to the thickness of the target skin. The treatment area encompassed the entire lesion plus a 2 mm. margin, with passes made in both vertical and horizontal directions until a pinpoint hemorrhage was observed. Immediately thereafter, 70% TCA was applied uniformly with gauze until the clinical endpoint of a homogenous, ivory-white frost was achieved. Post-procedure, patients were provided with topical gentamicin cream (Garamycin 0.1% 15 g cream) and instructed to apply zinc oxide cream twice daily, with caution against premature removal of any resulting crusts or desquamation. 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
localized vitiligo over one year vitiligo treatments within the past 3 months bleeding tendency, or on anticoagulant therapy individuals with a present or past history of cutaneous malignancy, moles, warts, or solar keratosis. Patients with a history of eczema, impetigo, herpes labialis, lichen planus, or psoriasis Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Child: 6 Year-12 Year,Infant: 13 Month(s)-24 Month(s),Middle Aged: 45 Year(s)-64 Year(s),Preschool Child: 2 Year-5 Year 1 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2023 the research ethical committee of faculty of medicine for boys in cairo Al Azhar university
Ethics Committee Address
Street address City Postal code Country
El Mkhaim El daem st Cairo 11682 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The degree of repigmentation was evaluated using a 5-point Physician’s Global Assessment (PGA) scale 6 months after procedure
Secondary Outcome side effects from the procedure 6 months after the procedure
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Al Husain University Hospital Al Husain St Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Al Azhar university Al Husain st Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university Al mokaim El daim st cairo Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Abouelhamd dr.ahmedabouelhamd10@gmail.com 00201009519234 6th of October city
City Postal code Country Position/Affiliation
Giza Egypt Resident doctor of Dermatology Venereology and Andrology
Role Name Email Phone Street address
Public Enquiries Ibrahim Shaheen ibshaheen@yahoo.com 00201012918083 Helwan city
City Postal code Country Position/Affiliation
Cairo Egypt Professor of Dermatology Venereology and Andrology
Role Name Email Phone Street address
Scientific Enquiries Mohamed Abdelmawgoud Amerrom@yahoo.com 00201141804081 Tanta city
City Postal code Country Position/Affiliation
Gharbia Egypt Assistant professor of Dermatology Venereology and Andrology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification(text, tables, figures, and appendices). Study Protocol Beginning 9 months and ending 36 months following article publication. open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 11/08/2025 PACTR Admin 01 Jan 2024