Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

NCT ID: NCT00907062

Last Updated: 2010-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2009-11-30

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.

Conditions

Vitiligo Vulgaris

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Gingko biloba

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

Group Type: EXPERIMENTAL

Ginkgo biloba

Intervention Type: DIETARY_SUPPLEMENT

60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill

Interventions

Ginkgo biloba

60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Interdisciplinary Network Complementary & Alternative Medicine Research

OTHER

Sponsor Role: collaborator

University of Toronto

OTHER

Sponsor Role: lead

Responsible Party

Leslie Dan Faculty of Pharmacy, University of Toronto

Principal Investigators

Orest Szczurko, ND MSc(cand)

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Leslie Dan Faculty of Pharmacy

Heather Boon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto, Leslie Dan Faculty of Pharmacy

Locations

Noumena Naturopathic Health Clinic

Mississauga, Ontario, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 12780716 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21406109 (View on PubMed)

Related Links

http://www.vitiligoresearch.org

study recruitment website, providing study details, consent forms, etc

Other Identifiers

REB 23373

Identifier Type: -

Identifier Source: secondary_id

NHPD#-137767

Identifier Type: -

Identifier Source: org_study_id