sefulness of photochemotherapy and phototherapy in adult patients with white patches in Eastern India
- Conditions
- Health Condition 1: null- Vitiligo
- Registration Number
- CTRI/2017/05/008473
- Lead Sponsor
- Medical College Kolkata
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 56
Nonsegmental vitiligo affecting > 5% and up to 70% of the body
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A. Effectiveness parameter by <br/ ><br>1. Mean area of repigmentation <br/ ><br>2. Vitiligo area scoring index <br/ ><br>3. Patients global assessment of disease activity improvement (5 point Likert scale) <br/ ><br>4. Physiciansâ?? global assessment of disease activity improvement (5 point Likert scale) <br/ ><br>5. Graphical representation of Body Surface Area <br/ ><br>B. Safety of two treatment arms <br/ ><br>1. Laboratory parameters <br/ ><br>2. Adverse events noted by physician <br/ ><br>3. Adverse events spontaneously reported by the patients <br/ ><br>Timepoint: A. Effectiveness parameters at 4th, 8th, 12th, 16th, 20th, 24th, 28th, 32nd, 36th, 40th, 44th, 48th follow-up visit <br/ ><br>B. Laboratory parameters at baseline, 24th and 48th follow-up visits
- Secondary Outcome Measures
Name Time Method Quality of Life in both treatment arms by DLQITimepoint: Baseline and end of visit follow-ups