Clinical trial NCT06877455: Topical Methotrexate with Fractional CO2 Laser in Treatment of Non Segmental Vitiligo
Official title: Efficacy of Topical Methotrexate with Fractional CO2 Laser Versus Topical Methotrexate Alone in Treatment of Non Segmental Vitiligo
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vitiligo
Keywords: fractional
co2 laser
vitiligo
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: One side of each participant's body will receive fractional CO2 laser combined with methotrexate 1% gel, while the other side will receive topical methotrexate alone, with treatments randomized to avoid bias. The laser therapy consists of four sessions at three-week intervals using specific parameters. Participants will be followed up for six months, with assessments at baseline, during treatment, and post-treatment.
Primary purpose: TREATMENT

Brief summary: This prospective, within subject clinical trial aims to evaluate the efficacy of combining fractional CO2 laser with topical methotrexate versus topical methotrexate alone in treating non-segmental vitiligo. Patients with comparable lesions on both sides of their body will receive both treatments randomly assigned to each side. The study assesses repigmentation, safety, patient satisfaction, and quality of life over six months.

Detailed description: The study is a prospective, within subject, self-controlled, randomized clinical trial conducted at the Department of Dermatology, Assiut University. Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent. Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compromised immune function, and skin type 1 with phototherapy allergy.

Intervention and Follow-Up One side of each participant's body will receive fractional CO2 laser combined with methotrexate 1% gel, while the other side will receive topical methotrexate alone, with treatments randomized to avoid bias. The laser therapy consists of four sessions at three-week intervals using specific parameters. Participants will be followed up for six months, with assessments at baseline, during treatment, and post-treatment.

Outcome Measures The primary outcome is the percentage of repigmentation, assessed through standardized digital photographs evaluated by blinded dermatologists. Secondary outcomes include safety evaluation, patient satisfaction, the pattern of repigmentation, the Vitiligo Area Scoring Index (VASI) score, and quality of life measured using a validated questionnaire.

Methods for Evaluation Photographs will be taken under Wood's lamp examination at baseline, before each treatment session, and two months after the final treatment. The efficacy will be evaluated by comparing pre- and post-treatment photographs. Safety and patient satisfaction will be assessed throughout the study period. The study aims to provide evidence on the effectiveness of combining fractional CO2 laser with topical methotrexate for vitiligo treatment.

Eligibility criteria: Inclusion Criteria:

* Participants are patients aged 18-65 with stable non-segmental vitiligo, having comparable lesions on both sides of their body. They must not have received corticosteroid or phototherapy treatments in the last three months and must provide informed consent.

Exclusion Criteria:

* Exclusion criteria include other skin diseases, pregnancy, severe organ dysfunction, compro

Primary outcomes:
measure: percentage of repigmentation
timeFrame: 6months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Abdelmaksoud A, Dave DD, Lotti T, Vestita M. Topical methotrexate 1% gel for treatment of vitiligo: A case report and review of the literature. Dermatol Ther. 2019 Sep;32(5):e13013. doi: 10.1111/dth.13013. Epub 2019 Jul 16.