Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00907062
Recruitment Status : Completed
First Posted : May 22, 2009
Last Update Posted : July 8, 2010
Sponsor:
Collaborator:
Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
Information provided by:
University of Toronto

Tracking Information
First Submitted Date  ICMJE May 21, 2009
First Posted Date  ICMJE May 22, 2009
Last Update Posted Date July 8, 2010
Study Start Date  ICMJE May 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
Vitiligo European Task Force assessment form [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00907062 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2009)
  • Vitiligo Area Scoring Index [ Time Frame: 12 weeks ]
  • Health Canada - Canada Vigilence Adverse Reaction Form [ Time Frame: 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents
Official Title  ICMJE 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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo Vulgaris
Intervention  ICMJE Dietary Supplement: Ginkgo biloba
60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill
Study Arms  ICMJE 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 21, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00907062
Other Study ID Numbers  ICMJE NHPD#-137767
REB 23373
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heather Boon, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
Study Sponsor  ICMJE University of Toronto
Collaborators  ICMJE Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
Investigators  ICMJE
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
PRS Account University of Toronto
Verification Date July 2010

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