Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitiligo Vulgaris

Intervention / Treatment
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* Dietary Supplement: Ginkgo biloba


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gingko biloba<br>60 mg of Ginkgo biloba (standardized to 15 mg ginkgofavonglycosides) given 2 times per day, with food, for 12 weeks. | Dietary Supplement: Ginkgo biloba<br>* 60 mg Ginkgo biloba per capsule, standardized to 15 mg ginkgofavonglycosides per pill<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitiligo, leucoderma