Study of effectiveness and side effects of light therapy with oral medication called "Khellin" in Vitiligo patients.

Not yet recruiting

• Conditions: Vitiligo,

• Registration Number: CTRI/2020/02/023495
• Lead Sponsor: Dr Lavin Bhatia

Brief Summary

Vitiligo is an acquired condition resulting in loss of melanocytes causing localized depigmentation affecting 0.5 – 1% of the world’s population. Although it is not a life-threatening condition but it causes severe disï¬guration and considerable emotional and social distress. Both local and systemic PUVA therapies remain ï¬rst-line methods for treating the disease. However, side effects like nausea, headache, vomiting, increased liver transaminases, severe photo-toxic reactions are common in systemic PUVA treatment. These side effects justify the research for photochemotherapeutic agent like Khellin with possible less side effects and potentially same efficacy. In this study, we focus on adding information to the literature about efficacy and adverse effects of KUVA - SOL therapy ( Khellin UV-A SOL) which is a ptomising treatment option for vitiligo. The study will recruit patients who are to be initiated on KUVA SOL therapy coming to Kasturba Hospital, Manipal SKIN OPD.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-02-20
• Study Start: 2020-02-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• 1.Patients with stable lesions.
• 2.Patients between 18 and 60 years of age.
• 3.Patients who give informed consent for the study and photography.
• 4.Patients who can follow up in the opd.

Exclusion Criteria

• 1.Patients who are unwilling to participate in the study.
• 2.Patients who had used any topical treatment 2 weeks and systemic treatment 4 weeks before starting on KUVA SOL.
• 3.Patients with history of photosensitive disorders, skin cancer, hepatic or renal disease and lesions over genitals.
• 4.Pregnant or lactating women.
• 5.Unstable vitiligo.
• 6.Patients with spontaneous repigmentation of depigmented macules.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.VASI ( Vitiligo Area Scoring Index)	Every 4 weeks of initiating therapy for total of 16 weeks.
2.VIDA ( Vitiligo Disease Activity)	Every 4 weeks of initiating therapy for total of 16 weeks.
3.VAS ( Visual Analogue Scale)	Every 4 weeks of initiating therapy for total of 16 weeks.
4.Scoring by Dermosopy Image Processing Methodology.	Every 4 weeks of initiating therapy for total of 16 weeks.
5. Side Effects.	Every 4 weeks of initiating therapy for total of 16 weeks.

Secondary Outcome Measures

Name	Time	Method
1. Liver function tests.	2. Renal function tests.

Trial Locations

Locations (1)

KASTURBA HOSPITAL, Manipal; 🇮🇳 Udupi, KARNATAKA, India

KASTURBA HOSPITAL, Manipal

🇮🇳Udupi, KARNATAKA, India

DR LAVIN BHATIA

Principal investigator

8369098740

bhatialavin700@gmail.com