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
  Purpose

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.


Condition Intervention Phase
Vitiligo Vulgaris
Dietary Supplement: Ginkgo biloba
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents: an Open Label Pilot Clinical Trial

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Vitiligo European Task Force assessment form [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 12
Study Start Date: May 2009
Study Completion Date: November 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gingko biloba
60 mg of Ginkgo biloba (standardized to 15 mg ginkgofavonglycosides) given 2 times per day, with food, for 12 weeks.
Dietary Supplement: Ginkgo biloba
60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00907062

Locations
Canada, Ontario
Noumena Naturopathic Health Clinic
Mississauga, Ontario, Canada, L5H 1H2
Sponsors and Collaborators
University of Toronto
Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Heather Boon, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto
ClinicalTrials.gov Identifier: NCT00907062     History of Changes
Other Study ID Numbers: NHPD#-137767, REB 23373
Study First Received: May 21, 2009
Last Updated: July 7, 2010
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by University of Toronto:
vitiligo
leucoderma

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014