Clinical Trial: Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents: an Open Label Pilot Clinical Trial
Brief Summary: Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. One study investigating the use of Ginkgo biloba for the treatment of vitiligo in adults reports effectiveness, but has significant flaws. We endeavor to conduct an open label pilot clinical trial replicating the previous trial on 12 adolescents 12 to 18 years old. The purpose of the pilot is to test the feasibility of recruitment and patient retention, variability of outcome measures, and identify major safety concerns. The pilot will use 60 mg of standardized G. biloba two times per day (BID) for 12 weeks. The primary outcome will be the validated Vitiligo European Task Force (VETF) evaluation form, secondary outcomes will include the Vitiligo Area Scoring Index (VASI), assess repigmentation via photographs, and will monitor and report adverse reactions.
Detailed Summary:
Sponsor: University of Toronto
Current Primary Outcome: Vitiligo European Task Force assessment form [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Vitiligo Area Scoring Index [ Time Frame: 12 weeks ]
- Health Canada - Canada Vigilence Adverse Reaction Form [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: University of Toronto
Dates:
Date Received: May 21, 2009
Date Started: May 2009
Date Completion:
Last Updated: July 7, 2010
Last Verified: July 2010
