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Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

Primary Purpose

Vitiligo Vulgaris

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Ginkgo biloba
Sponsored by
University of Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo Vulgaris focused on measuring vitiligo, leucoderma

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Noumena Naturopathic Health Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gingko biloba

Arm Description

60 mg of Ginkgo biloba (standardized to 15 mg ginkgofavonglycosides) given 2 times per day, with food, for 12 weeks.

Outcomes

Primary Outcome Measures

Vitiligo European Task Force assessment form

Secondary Outcome Measures

Vitiligo Area Scoring Index
Health Canada - Canada Vigilence Adverse Reaction Form

Full Information

First Posted
May 21, 2009
Last Updated
July 7, 2010
Sponsor
University of Toronto
Collaborators
Canadian Interdisciplinary Network Complementary & Alternative Medicine Research
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1. Study Identification

Unique Protocol Identification Number
NCT00907062
Brief Title
Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents
Official Title
Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents: an Open Label Pilot Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Toronto
Collaborators
Canadian Interdisciplinary Network Complementary & Alternative Medicine Research

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo Vulgaris
Keywords
vitiligo, leucoderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gingko biloba
Arm Type
Experimental
Arm Description
60 mg of Ginkgo biloba (standardized to 15 mg ginkgofavonglycosides) given 2 times per day, with food, for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginkgo biloba
Intervention Description
60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill
Primary Outcome Measure Information:
Title
Vitiligo European Task Force assessment form
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Vitiligo Area Scoring Index
Time Frame
12 weeks
Title
Health Canada - Canada Vigilence Adverse Reaction Form
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Orest Szczurko, ND MSc(cand)
Organizational Affiliation
University of Toronto, Leslie Dan Faculty of Pharmacy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heather Boon, PhD
Organizational Affiliation
University of Toronto, Leslie Dan Faculty of Pharmacy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noumena Naturopathic Health Clinic
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5H 1H2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
12780716
Citation
Parsad D, Pandhi R, Juneja A. Effectiveness of oral Ginkgo biloba in treating limited, slowly spreading vitiligo. Clin Exp Dermatol. 2003 May;28(3):285-7. doi: 10.1046/j.1365-2230.2003.01207.x.
Results Reference
background
PubMed Identifier
21406109
Citation
Szczurko O, Shear N, Taddio A, Boon H. Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial. BMC Complement Altern Med. 2011 Mar 15;11:21. doi: 10.1186/1472-6882-11-21.
Results Reference
derived
Links:
URL
http://www.vitiligoresearch.org
Description
study recruitment website, providing study details, consent forms, etc

Learn more about this trial

Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

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