Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

Vitiligo Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00907062
• Other study ID #: NHPD#-137767
• Secondary ID: REB 23373
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2009
• Last updated: July 7, 2010
• Start date: May 2009
• Est. completion date: November 2009

Study information

• Verified date: July 2010
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo
• Vitiligo Vulgaris

Intervention

Dietary Supplement:
• Ginkgo biloba
60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill

Locations

Country	Name	City	State
Canada	Noumena Naturopathic Health Clinic	Mississauga	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Interdisciplinary Network Complementary & Alternative Medicine Research

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitiligo European Task Force assessment form		12 weeks	No
Secondary	Vitiligo Area Scoring Index		12 weeks	No
Secondary	Health Canada - Canada Vigilence Adverse Reaction Form		12 weeks	Yes

External Links

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