Comparison of Efficacy and Safety Psoralen Combined With Ultraviolet A (PUVA) Vs Tofacitinib in the Treatment of Generalized Vitiligo.

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHayat Abad Medical Complex, Peshawar

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 volunteers

Qualifiers

• 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

Design model

Parallel

Treatments tested in this trial

  • Group A recieving PUVA therapy

    Drug

    This group A will recieve PUVA therapy twice weekly for 6 months

  • Group B receiving Tablet Tofacitinib

    Drug

    This group will be given tablet Tofacitinib 5mg twice daily for 6 months

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Group A in which the patient will recieve PUVA therapyOther 1 intervention
Group B: Group B in which the patient will be given Tofacitinib 5mgOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Six Months

Secondary outcomes

Other outcomes

Sponsors and contacts

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