Health Condition 1: null- Vitiligo
Conditions
Interventions
Intervention1: PUVA: Trimethylpsoralen (0.6 mg/kg) with food, 2 hours before food on days of exposure. Standard initial dose of 2 J/cm2 started on all patients and increased by 0.5J/cm2 for each subse
Sponsors
Medical College Kolkata
Eligibility
Inclusion criteria
Inclusion criteria: Nonsegmental vitiligo affecting > 5% and up to 70% of the body
Exclusion criteria
Exclusion criteria: 1. Age younger than 12years or older than 60years. 2. Previous skin malignancy, photodermatoses, SLE, porphyria, solar urticaria, photo contact dermatitis, previous failure of or intolerance to photo chemotherapy. 3. Treatment of vitiligo within last 3 months (phototherapy, systemic therapy, or topical therapy with corticosteroid agents, vitamin D analogues, or tacrolimus). 4. Pregnancy, lactation, renal or hepatic disease, lupus erythematosus, a history of photosensitivity, or administration of a drug known frequently to cause photosensitization. 5. History of hypersensitivity to any of the study drugs 6. Patients not willing to comply with protocol requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A. Effectiveness parameter by 1. Mean area of repigmentation 2. Vitiligo area scoring index 3. Patients global assessment of disease activity improvement (5 point Likert scale) 4. Physiciansâ?? global assessment of disease activity improvement (5 point Likert scale) 5. Graphical representation of Body Surface Area B. Safety of two treatment arms 1. Laboratory parameters 2. Adverse events noted by physician 3. Adverse events spontaneously reported by the patients Timepoint: A. Effectiveness parameters at 4th, 8th, 12th, 16th, 20th, 24th, 28th, 32nd, 36th, 40th, 44th, 48th follow-up visit B. Laboratory parameters at baseline, 24th and 48th follow-up visits | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of Life in both treatment arms by DLQITimepoint: Baseline and end of visit follow-ups | — |
Countries
India
Contacts
Public ContactDr Karan Sancheti
Associate Professor Department of Dermatology Medical College, Kolkata
Outcome results
None listed