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Study comparing two treatment methods using lasers and tofacitinib to improve skin color in vitiligo on hands and feet.

Comparative Efficacy of CO2 Laser-Assisted Topical Tofacitinib Delivery Combined with Excimer Laser Versus Topical Tofacitinib with Excimer Laser for Acral Vitiligo: A Randomized, Intraindividual Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096891
Enrollment
20
Registered
2025-11-04
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L80- Vitiligo

Interventions

Intervention1: Fractional CO2 laser–assisted topical tofacitinib (2 percent ointment) combined with 308 nm excimer laser therapy: CO2 laser: DEEP FX mode, 17.5–22.5 J/cm2, 10 percent density, 300 Hz,

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Phototherapy naïve adults aged 18–50 years with clinically diagnosed acral vitiligo (affecting hands and/or feet). 2. Stable vitiligo for at least 6 months prior to enrolment, defined by no new lesions or expansion of existing lesions. 3. Vitiligo Disease Activity (VIDA) score of 0–1, indicating stable or minimally active disease. 4. Symmetric or comparable bilateral acral lesions suitable for intraindividual comparison 5. Willingness to comply with study procedures and avoid other vitiligo treatments during the trial.

Exclusion criteria

Exclusion criteria: 1. Active or progressive vitiligo (VIDA score greater than 1). 2. History of hypersensitivity to tofacitinib, laser therapy, or excimer light. 3. Concomitant skin conditions (e.g., psoriasis, eczema) that could interfere with assessments. 4. Systemic immunosuppressive therapy within 4 weeks or topical treatments (including JAK inhibitor) within 4 weeks prior to enrolment. 5. Comorbidities such as active infection, malignancy, or severe hepatic/renal impairment. 6. Pregnancy, lactation, or inadequate contraception in women of childbearing potential

Design outcomes

Primary

MeasureTime frame
Proportion of target acral vitiligo lesions achieving 50 percent or more repigmentation at week 24, assessed by standardized digital planimetry with blinded evaluation.Timepoint: After 24 Week

Secondary

MeasureTime frame
Proportion of lesions with 75 percent and 90 percent or more repigmentation, mean percentage improvement in TL VESplus score, time to onset of 10 percent repigmentation, physician and patient global assessment of repigmentation, durability of response at week 36 with maintenance of 50 percent repigmentation without 25 percent loss, and incidence of adverse events, pain scores, and local reactions.Timepoint: After 24 Week

Countries

India

Contacts

Public ContactDr Madura C

CUTIS Academy of Cutaneous Sciences

maduradr@gmail.com9632741998

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026