Adding methotrexate to NCES for stable acral and resistant vitiligo
The Value of Using Methotrexate Therapy Along With Non Cultured Epidermal Cell Suspension (NCES) in Stable Resistant Vitiligo: An Interventional Prospective Randomized Controlled Trial.
This trial tests whether a six-month course of oral methotrexate given around the time of non‑cultured epidermal suspension (NCES) improves repigmentation in adults with stable acral or resistant vitiligo on the elbows and knees.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cairo University Academic / other |
| Drugs / interventions | Methotrexate |
| Locations | 1 site (Cairo) |
| Trial ID | NCT07352293 on ClinicalTrials.gov |
What this trial studies
Researchers will compare outcomes of NCES in two groups of adults with stable acral or resistant vitiligo: one group will receive oral methotrexate for three months before and three months after the NCES procedure, while the other group will not receive methotrexate. All participants will receive PUVA for hands and feet three times per week for three months after NCES, and they will be followed monthly to document repigmentation. The trial enrolls adults (≥18 years) with non‑segmental vitiligo stable for at least one year and excludes segmental or active disease, pregnancy, and significant hematologic, hepatic, or renal conditions. Outcomes focus on degree and speed of repigmentation at treated sites over the follow‑up period.
Who should consider this trial
Good fit: Adults (18+) with non‑segmental, stable (≥1 year) acral or treatment‑resistant vitiligo on the elbows or knees who have not responded to conventional therapies and meet safety criteria are the intended participants.
Not a fit: Patients with segmental or active vitiligo, pregnant women, those with significant blood, liver, or kidney disease, or those recently treated with topical or systemic therapies are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, adding methotrexate could increase the amount and speed of repigmentation after NCES for resistant acral vitiligo.
How similar studies have performed: Prior work shows methotrexate can help stabilize vitiligo and that NCES plus phototherapy can improve repigmentation, but combining perioperative methotrexate specifically with NCES for acral lesions has limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion criteria: * Patients with non-segmental vitiligo (NSV) with acral or resistant lesions over the elbows and knees, that has not responded to conventional treatment * Stability for ≥ 1 year * Age ≥18 years * Exclusion criteria: * Segmental vitiligo * Active vitiligo; new lesions, expansion of old lesions, confetti like lesions, ill-defined edges or koebnerization in \< 1 year * Age \< 18 years. * Pregnant females. * Patients with hematologic, hepatic, renal disease or chronic infection. * Topical treatment in the past month and systemic treatment in the past 3 months.
Where this trial is running
Cairo
- Dermatology Outpatient Clinic, Kasr al Ainy Teaching Hospital, Cairo University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Nanis Ragab, MD
- Email: nanisragab@kasralainy.edu.eg
- Phone: +2 1227449161
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.