About this trial
This study aims to compare the efficacy and safety of PUVA versus Tofacitinib in the treatment of generalized vitiligo. Given the high prevalence of vitiligo in Pakistan and the significant psychosocial impact on patients, particularly in Peshawar, this study will provide valuable insights into optimal treatment strategies.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
• Patients of either gender aged 18-60 years, diagnosed with generalized vitiligo (depigmentation affecting more than 10% of the body surface area).
Stable vitiligo (no new lesions or progression of existing lesions in the last three months).
Disqualifiers
Patients with a history of photosensitivity or allergies to Psoralen or Tofacitinib in order to prevent adverse reactions that could compromise patient safety and interfere with treatment efficacy assessment.
Pregnant or lactating women in order to ensure fetal and neonatal safety, as the effects of Psoralen and Tofacitinib on pregnancy and breastfeeding are not well studied and could pose potential risks.
Trial design
Parallel
Treatments tested in this trial
Group A recieving PUVA therapy
DrugThis group A will recieve PUVA therapy twice weekly for 6 months
Group B receiving Tablet Tofacitinib
DrugThis group will be given tablet Tofacitinib 5mg twice daily for 6 months
Treatment groups
Trial outcomes
Primary outcomes
Assesment of repigmentation
Efficacy in this study will refer to the degree of repigmentation achieved, which will be measured using the Vitiligo Area Scoring Index (VASI) (Annex-1) to assess the percentage of repigmented skin in affected areas. A treatment will be deemed effective if it achieves at least 50% repigmentation in depigmented patches, as evaluated by VASI over a six-month period.
Sponsors and contacts
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