Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo

• Conditions: Vitiligo

• Registration Number: NCT01006421
• Lead Sponsor: King Saud University

Brief Summary

Vitiligo is a common chronic skin disease with 1-4% prevalence. It has a significant psychosocial impact on patients and society. Different treatment modalities with variable success rates are available.

Phototherapy is among the successful treatments but gives modest results. Some reports documented the usefulness of Ginkgo Biloba (GB) when used alone in Vitiligo treatment.

Detailed Description

Adding GB to phototherapy, especially the most commonly used one; Narrow-Band UVB (NBUVB) might give better results than using either one alone. This might improve repigmentation as well as patients' quality-of-life. (QOL).

This will be a prospective double-blind randomized controlled clinical trial. One-hundred-sixty Vitiligo patients will be randomly divided into 2 groups( 80 patients per group).

One group will receive oral GB (2 tablets of 60 mgs twice daily) with NBUVB twice weekly.

The other group will receive placebo tablets( identical in size, shape and color) to GB twice daily with NBUVB twice weekly.

Both groups will be treated for 6 months. Standard protocol of phototherapy will be used for both groups.

Our aim here is to see whether adding GB to NBUVB will lead to better repigmentation than placebo or not.

Study Timeline

• Study Start: 2009-01
• Status Verified: 2009-11
• Study First Submitted: 2009-11-01
• Study First Submitted QC: 2009-11-01
• Study First Posted: 2009-11-01
• Last Update Submitted: 2009-11-04
• Last Update Posted: 2009-11-05
• Study Completion: 2011-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Any Vitiligo patient (age 12 years and above) with non-segmental Vitiligo.
• Body surface area (BSA) involvement ≥ 3%.

Exclusion Criteria

• Unable to consent
• Any topical, systemic or phototherapy for Vitiligo in the previous 2 months.
• Pregnancy, breast feeding.
• Liver or kidney disease.
• Epilepsy
• Bleeding disorder or anticoagulant treatment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Repigmentation (more than 50% from baseline) as the primary outcome	3,6 and 9 months

Secondary Outcome Measures

Name	Time	Method
Quality-of-life - as secondary outcome .	3,6 and 9 months

Trial Locations

Locations (1)

King Khalid University Hospital; 🇸🇦 Riyadh, Central, Saudi Arabia