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A comparative study on efficacy, safety and tolerability of topical tofacitinib vs topical tofacitinib combined with puvasol in the management of vitiligo

Phase 3
Recruiting
Conditions
Health Condition 1: L80- Vitiligo
Registration Number
CTRI/2023/12/060436
Lead Sponsor
Dr Rohini Rathod
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1)Patients who are clinically diagnosed cases of vitiligo

2)Both sexes – males and females

3)Age – above 12 years to 60 years

4)Body surface area involving the depigmented patches of less than 10%

5)Depigmented patches in exposed areas of the body

Exclusion Criteria

1)Patients having vitiligo patches in more than 10% BSA and having patches over flexure areas and genitals

2)Patients with active or latent TB

3)Patients with anaemia (Hb < 9g/dl) ,liver diseases, kidney disease, GI disease (diverticulitis, perforation ,ulcers ) , respiratory disease (ILD , COPD, pulmonary edema)

4)Patients with malignancies or lymphoproliferative disorders

5)Patients on potent immunosuppresants, biological DMARDS , H/O organ transplant

6)Patients with deranged lipid profile

7)H/O recent live vaccination

8)Age less than 12 years, pregnancy and lactation

9)Family history of melanoma/non melanoma skin cancers

10)People suffering from photosensitivity disorders

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To assess the clinical efficacy of topical tofacitinib vs topical tofacitinib with puvasol in vitiligo patients with respect to repigmentation of skinTimepoint: 4 months
Secondary Outcome Measures
NameTimeMethod
To know the safety and tolerability of topical tofacitinib vs topical tofacitinib with puvasol in treatment of vitiligo. <br/ ><br> <br/ ><br>Timepoint: 4 months
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