Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents: an Open Label Pilot Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Vitiligo Vulgaris
• Intervention / Treatment: Dietary supplement: Ginkgo biloba

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Mississauga, Ontario, Canada, L5H 1H2
      • Noumena Naturopathic Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Vitiligo European Task Force assessment form	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Vitiligo Area Scoring Index	12 weeks
Health Canada - Canada Vigilence Adverse Reaction Form	12 weeks

Collaborators and Investigators

• Sponsor: University of Toronto
• Collaborators: 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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): November 1, 2009

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 21, 2009
• First Posted (Estimate): May 22, 2009

Study Record Updates

• Last Update Posted (Estimate): July 8, 2010
• Last Update Submitted That Met QC Criteria: July 7, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: vitiligo; leucoderma
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo
• Other Study ID Numbers: NHPD#-137767; REB 23373