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

November 4, 2009 updated by: King Saud University

Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Saudi Arabia
    • Central
      • Riyadh, Central, Saudi Arabia
        • Recruiting
        • King Khalid University Hospital
        • Contact:
        • Principal Investigator:
          • KHALID M ALGHAMDI, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

DERMATOLOGY CLINIC

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Repigmentation (more than 50% from baseline) as the primary outcome
Time Frame: 3,6 and 9 months
3,6 and 9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality-of-life - as secondary outcome .
Time Frame: 3,6 and 9 months
3,6 and 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Collaborators

University Hospital

Investigators

  • Study Chair: KHALID M ALGHAMDI, MD, KSU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Study Completion (Anticipated)

January 1, 2011

Study Registration Dates

First Submitted

November 1, 2009

First Submitted That Met QC Criteria

November 1, 2009

First Posted (Estimate)

November 1, 2009

Study Record Updates

Last Update Posted (Estimate)

November 5, 2009

Last Update Submitted That Met QC Criteria

November 4, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GB-NBVUB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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