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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607567738879 Date of Registration: 14/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Microneedling with methotrexate versus intralesional steroid in the treatment of localized vitiligo
Official scientific title Microneedling with methotrexate versus intralesional steroid in the treatment of localized vitiligo
Brief summary describing the background and objectives of the trial Vitiligo is a common acquired depigmenting disorder characterized by the progressive loss of functional melanocytes, resulting in well-demarcated depigmented macules and patches. Despite the availability of several therapeutic modalities, the management of localized vitiligo remains challenging because of the variable clinical response and frequent disease recurrence. This study aimed to evaluate and compare the safety and efficacy of microneedling-assisted methotrexate delivery with intralesional corticosteroid therapy in the treatment of localized vitiligo.
Type of trial RCT
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 25/04/2023
Actual trial start date 25/04/2023
Anticipated date of last follow up 01/03/2027
Actual Last follow-up date
Anticipated target sample size (number of participants) 36
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously 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 Intralesional steroids Treatment was used once every 2 weeks, for a maximum of 6 sessions The intralesional steroids' original strength (epirelefan ® 40 mg/ml) was 40 mg/ml. Intradermally, one-fourth-diluted triamcinolone acetonide (2.5 mg/ml TrA) has been administered at 1-cm intervals, with an injection volume of 0.05–0.1 ml/site. With a 0.5-inch-long, 30-gauge needle connected to an insulin syringe, a maximum of 2 mL can be injected. Treatment was used once every 2 weeks, for a maximum of 6 sessions. 36 Active-Treatment of Control Group
Experimental Group Microneedling with methotrexate The treatment will be administered once every two weeks for a maximum of 6 sessions Microneedling with methotrexate is typically administered by performing a microneedling procedure using a device with fine needles to create microscopic punctures in the skin, followed by the application of a topical methotrexate medication. Typically, in the range of 0.1 to 0.5 mg/cm2 of affected skin. The treatment will be administered once every two weeks for a maximum of 6 sessions 36
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Co-operative patient who is willing and able to comply with the treatment protocol and follow-up visits. Participants must have stable vitiligo, meaning that the extent and severity of their vitiligo have not significantly changed in the past 6 months Patients with keloidal tendency. Patients receiving topical or systemic treatment for vitiligo and phototherapy during the previous 6 months. Patients with active lesions. Participants with a history of hypersensitivity to methotrexate or any of its excipients. Participants with a history of liver disease or liver function abnormalities. Participants with a history of bleeding disorders or receiving anticoagulant therapy. Participants who are pregnant or breastfeeding. Participants with active skin infections or skin conditions that would contraindicate the use of microneedling or intralesional injections. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 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 14/02/2023 research ethics committee
Ethics Committee Address
Street address City Postal code Country
King Faisal ST Assuit 71524 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the degree of repigmentation 3 months after trreatment
Secondary Outcome complications of the procedure 3 months after trreatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Dermatology King Faisal ST Assuit 71524 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Department of Dermatology King Faisal ST Assuit 71524 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Al Azhar university king faisal st Assuit Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Aya Ibrahim aya_only9446@yahoo.com 00201008826314 king faisal st
City Postal code Country Position/Affiliation
Assuit Egypt Resident physician in dermatology
Role Name Email Phone Street address
Scientific Enquiries Khaled tawfik dr.khalidderma70@yahoo.com 00201141804081 Malawy St
City Postal code Country Position/Affiliation
Minya Egypt professor of Dermatology
Role Name Email Phone Street address
Public Enquiries Mofreh Ismail Mofrehmansour@gmail.com 002012769503 king fisal st
City Postal code Country Position/Affiliation
Assuit Egypt Assistant professor of Dermatology Venereology and Andrology Faculty of Medicine AlAzhar University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All individual participant data that underlie the results reported in this study will be available after de-identification to researchers who provide a methodologically sound proposal Study Protocol 6 months after publication and extend to 36 months after 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 Trial description 07/07/2026 more description of the background Vitiligo is a common acquired depigmenting disorder characterized by the progressive loss of functional melanocytes, resulting in well-demarcated depigmented macules and patches. Despite the availability of several therapeutic modalities, the management of localized vitiligo remains challenging because of the variable clinical response and frequent disease recurrence. This study aimed to evaluate and compare the safety and efficacy of microneedling-assisted methotrexate delivery with intralesional corticosteroid therapy in the treatment of localized vitiligo.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 14/07/2026 PACTR Admin 25 Apr 2023