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Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

This study has been completed.
Sponsor:
Collaborator:
Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00907062
First received: May 21, 2009
Last updated: July 7, 2010
Last verified: July 2010

May 21, 2009
July 7, 2010
May 2009
October 2009   (final data collection date for primary outcome measure)
Vitiligo European Task Force assessment form [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00907062 on ClinicalTrials.gov Archive Site
  • Vitiligo Area Scoring Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Health Canada - Canada Vigilence Adverse Reaction Form [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents
Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents: an Open Label Pilot Clinical Trial

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vitiligo Vulgaris
Dietary Supplement: Ginkgo biloba
60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill
Experimental: Gingko biloba
60 mg of Ginkgo biloba (standardized to 15 mg ginkgofavonglycosides) given 2 times per day, with food, for 12 weeks.
Intervention: Dietary Supplement: Ginkgo biloba

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2009
October 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • • males and females

    • 12 to 18 years old
    • self selected candidates identifying themselves to suffer with vitiligo vulgaris of any duration
    • minimum VASI score of 4, no maximum score (corresponding to a 3cm2 completely (100%) depigmented lesion, or a 6cm2 50% depigmented lesion)
    • stable or progressing vitiligo
    • mentally competent subjects able to adhere to the given protocol and treatments administered as interventions
    • normal on physical examination at the pre-study intake, and in the case of abnormalities the health care practitioner considers them to be clinically insignificant
    • written and informed consent
    • the potential candidate must have a family doctor that they have seen in the last 12 months
    • negative pregnancy test for menstruating women and if sexually active, a willingness to practice adequate birth control for the duration of the trial
    • diagnosis of vitiligo confirmed by supervising medical doctor

Exclusion Criteria:

  • • use of medications contraindicated with Ginkgo biloba:

    • daily use of acetylsalicylic acid, ibuprofen, NSAIDs, fish oils, vitamin E
    • any prescription or use of blood thinners, anticoagulants, anti-platelet drugs, pentoxifylline, clotting factor replacements, antihypertensive medications, Thiazide diuretics, Acetylcholinesterase inhibitors, anticonvulsants, hypoglycemic agents, MAOI, SSRI, Nifedipine, Papaverine, Yohimgine, Sildenafil
    • history of diabetes, seizures, haemophilia
    • allergy or sensitivity to Ginkgo biloba or other constituents in the capsule
    • any treatment for vitiligo within the last 2 months
    • current use of Ginkgo biloba or within the last 2 months
    • mentally or physically incapacitated such that assent or informed consent cannot be obtained.
    • any history or other condition which the study physician regards as clinically significant to the study
    • a major illness considered to be clinically significant by the study physician within 2 months of the study start date
    • current participation in another intervention trial.
    • pregnancy or intent to become pregnant in the next 4 months
    • current alcoholism or substance abuse.
    • current history of tumors, any history of skin cancer
    • any current serious disorders determined to be clinically significant to the study.
    • breast feeding women
    • no prior skin grafts or surgeries, or scheduled surgeries of any kind.
    • any abnormalities on the INR, PTT, or CBC tests at baseline
Both
12 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00907062
NHPD#-137767, REB 23373
Yes
Heather Boon, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
University of Toronto
Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
Principal Investigator: Orest Szczurko, ND MSc(cand) University of Toronto, Leslie Dan Faculty of Pharmacy
Principal Investigator: Heather Boon, PhD University of Toronto, Leslie Dan Faculty of Pharmacy
University of Toronto
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP