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

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ClinicalTrials.gov Identifier: NCT01006421
Recruitment Status : Unknown
Verified November 2009 by King Saud University.
Recruitment status was:  Recruiting
First Posted : November 2, 2009
Last Update Posted : November 5, 2009
Sponsor:
Collaborator:
Information provided by:

Study Description
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.


Condition or disease Intervention/treatment
Vitiligo Dietary Supplement: GINGKO BILOBA

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 Design

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Oral Ginkgo Biloba and Narrow Band UVB in the Treatment of Vitiligo : A Randomized Double - Blind Placebo Controlled Trial
Study Start Date : January 2009
Estimated Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

Groups and Cohorts

Intervention Details:
    Dietary Supplement: GINGKO BILOBA
    MEMOREX 60 MG BID

Outcome Measures

Primary Outcome Measures :
  1. Repigmentation (more than 50% from baseline) as the primary outcome [ Time Frame: 3,6 and 9 months ]

Secondary Outcome Measures :
  1. Quality-of-life - as secondary outcome . [ Time Frame: 3,6 and 9 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
DERMATOLOGY CLINIC
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006421


Contacts
Contact: KHALID M ALGHAMDI, MD 4690815 kmgderm@yahoo.com

Locations
Saudi Arabia
King Khalid University Hospital Recruiting
Riyadh, Central, Saudi Arabia
Contact: KHALID M ALGHAMDI, MD    4690815    kmgderm@yahoo.com   
Principal Investigator: KHALID M ALGHAMDI, MD         
Sponsors and Collaborators
King Saud University
University Hospital
Investigators
Study Chair: KHALID M ALGHAMDI, MD KSU
More Information

Responsible Party: DR KHALID ALGHAMDI, KSU
ClinicalTrials.gov Identifier: NCT01006421     History of Changes
Other Study ID Numbers: GB-NBVUB
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: November 5, 2009
Last Verified: November 2009

Keywords provided by King Saud University:
phototherapy
Gingko biloba
repigmentation

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases