Study to compare effect of oral drug in vitiligo (Tofacitinib) along with ultraviolet ray therapy versus only ultraviolet ray therapy in vitiligo patients

Effect of oral Tofacitinib with NBUVB versus NBUVB alone to produce improvement in clinical and molecular marker of melanogenesis in unstable vitiligo: Investigator blind, randomized controlled trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/02/040658

Enrollment

Registered

2022-02-28

Start date

Unknown

Completion date

Unknown

Last updated

2022-04-04

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: Oral Tofacitinib 5 mg with Narrow Band Ultraviolet B phototherapy: Oral Tofacitinib 5 mg twice daily for 12 weeks with Narrow Band Ultraviolet B phototherapy twice weekly for 12 weeks C

Eligibility

Inclusion criteria

Inclusion criteria: 1. All clinically diagnosed cases of unstable vitiligo 2. No use of any systemic therapy for 4 weeks prior to enrollment in the study 3. Informed consent obtained 4. Willing for twice weekly treatment with narrow band ultraviolet B phototherapy.

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women. 2. Known Hyperlipidemic individual 3. Patient taking known photosensitizer drugs or immunosuppressive therapy. 4. Concomitant immune defects, heart disease, renal failure, malignancy. 5. Neurological or psychiatric disorders. 6. History of photosensitivity or photomediated disorder. 7. Participation in any clinical trial within the last 3 months 8. Substance or alcohol abuse.

Design outcomes

Primary

Measure	Time frame
Vitiligo Area Scoring Index (VASI)Timepoint: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks	—

Secondary

Measure	Time frame
Adverse reactions noted by the physicianTimepoint: 4 weeks, 8 weeks, 12 weeks, 16 weeks;Dermatology Life Quality Index (DLQI)Timepoint: baseline, 12 weeks;Routine haemogram, random blood sugar, urea, creatinine, liver function tests (LFT), Lipid profileTimepoint: screening visit, 4 weeks, 12 weeks;Tyrosinase (TYR), Tyrosinase Related Protein-1 (TYRP-1) and Micropthalmia associated Transcription Factor (MITF)Timepoint: Screening visit, 12 weeks;Vitiligo Disease Activity Score (VIDA)Timepoint: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks	—

Measure

Time frame

Adverse reactions noted by the physicianTimepoint: 4 weeks, 8 weeks, 12 weeks, 16 weeks;Dermatology Life Quality Index (DLQI)Timepoint: baseline, 12 weeks;Routine haemogram, random blood sugar, urea, creatinine, liver function tests (LFT), Lipid profileTimepoint: screening visit, 4 weeks, 12 weeks;Tyrosinase (TYR), Tyrosinase Related Protein-1 (TYRP-1) and Micropthalmia associated Transcription Factor (MITF)Timepoint: Screening visit, 12 weeks;Vitiligo Disease Activity Score (VIDA)Timepoint: baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks

—

Countries

India

Contacts

Public ContactProf Dr Nilay Kanti Das

Rampurhat Government Medical College and Hospital

drsilamrita@gmail.com9477737091

Outcome results

None listed

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