Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents
This study has been completed.
First Received on May 21, 2009. Last Updated on July 7, 2010 History of Changes
| Sponsor: | University of Toronto |
|---|---|
| Collaborator: | Canadian Interdisciplinary Network Complementary & Alternative Medicine Research |
| Information provided by: | University of Toronto |
| ClinicalTrials.gov Identifier: | NCT00907062 |
PurposeVitiligo 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.
| Condition | Intervention | Phase |
|---|---|---|
| Vitiligo Vulgaris | Dietary Supplement: Ginkgo biloba | Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents: an Open Label Pilot Clinical Trial |
Resource links provided by NLM:
Genetics Home Reference related topics: vitiligo
MedlinePlus related topics: Vitiligo
U.S. FDA Resources Further study details as provided by University of Toronto:
Primary Outcome Measures:
- Vitiligo European Task Force assessment form [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Vitiligo Area Scoring Index [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Health Canada - Canada Vigilence Adverse Reaction Form [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 12 |
| Study Start Date: | May 2009 |
| Study Completion Date: | November 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 12 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00907062
Locations
| Canada, Ontario | |
| Noumena Naturopathic Health Clinic | |
| Mississauga, Ontario, Canada, L5H 1H2 | |
Sponsors and Collaborators
University of Toronto
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 |
More InformationAdditional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Heather Boon, Associate Professor, Leslie Dan Faculty of Pharmacy, University of Toronto |
| ClinicalTrials.gov Identifier: | NCT00907062 History of Changes |
| Other Study ID Numbers: | NHPD#-137767, REB 23373 |
| Study First Received: | May 21, 2009 |
| Last Updated: | July 7, 2010 |
| Health Authority: | Canada: Canadian Institutes of Health Research |
Keywords provided by University of Toronto:
| vitiligo leucoderma |
Additional relevant MeSH terms:
| Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases |
ClinicalTrials.gov processed this record on February 14, 2012
Replies