Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

NCT00907062 | Completed Phase 1 DMC

• 2 other identifiers: NHPD#-137767REB 23373
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Keywords

vitiligo; leucoderma

Outcome Measures

Primary Outcomes (1)

• Vitiligo European Task Force assessment form

  12 weeks

Secondary Outcomes (2)

• Vitiligo Area Scoring Index

  12 weeks

• Health Canada - Canada Vigilence Adverse Reaction Form

  12 weeks

Study Arms (1)

Gingko biloba

EXPERIMENTAL

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

Dietary Supplement: Ginkgo biloba

Interventions

Ginkgo biloba DIETARY_SUPPLEMENT

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

Gingko biloba

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• males and females
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Interdisciplinary Network Complementary & Alternative Medicine Research: collaborator

Study Sites (1)

Noumena Naturopathic Health Clinic

Mississauga, Ontario, L5H 1H2, Canada

Location

Related Publications (2)

• 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.

  PMID: 12780716 BACKGROUND

• 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.

  PMID: 21406109 DERIVED

Related Links

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

MeSH Terms

Conditions

Vitiligo

Interventions

Ginkgo Extract

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Plant Extracts; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 21, 2009
• First Posted: May 22, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: July 8, 2010

Record last verified: 2010-07

Locations

CA (1)