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

NCT07055529 | Not Yet Recruiting Early Phase 1

• 1 other identifier: MTI-HMC Peshawar
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vitiligo, Generalized

Outcome Measures

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.

  Six Months

Study Arms (2)

Group A in which the patient will recieve PUVA therapy

OTHER

The Study will have two groups and in this group patients will recieve Psoralen combined with UVA (PUVA) therapy

Drug: Group A recieving PUVA therapy

Group B in which the patient will be given Tofacitinib 5mg

OTHER

This study will have two groups and this group will recieve tablet tofacitinib 5mg

Drug: Group B receiving Tablet Tofacitinib

Interventions

Group A recieving PUVA therapy DRUG

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

Also known as: Psoralen combined with Ultraviolet A

Group A in which the patient will recieve PUVA therapy

Group B receiving Tablet Tofacitinib DRUG

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

Group B in which the patient will be given Tofacitinib 5mg

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

MTI-HMC Peshawar

Peshawar, Khyber Pukhtunkhwa, 25000, Pakistan

Location

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sana Zaman Sana Zaman, FCPS Part II

CONTACT

92 317 6030615; zamansana16@gmail.com

Kamran Ullah Ullah, FCPS Part II

CONTACT

03429149403; kamran.ullah1983@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Medical Officer

Model Details: No additional details

Study Record Dates

• First Submitted: June 15, 2025
• First Posted: July 9, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 30, 2026

Record last verified: 2025-06

Locations

PA (1)