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Vitiligo VulgarisPhase 1NCT00907062

Ginkgo Biloba for the Treatment of Vitiligo Vulgaris in Adolescents

A Phase 1 study testing Ginkgo biloba in people with Vitiligo Vulgaris, run by University of Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Vitiligo Vulgaris
What is being tested?
Ginkgo biloba
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteCanada
Study dates
May 2009to Nov 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • • 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
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  • 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

Who cannot join

  • • 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
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Noumena Naturopathic Health Clinic

    Mississauga, Ontario, L5H 1H2

Other trials in Canada

About this study

Official title: 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.

Being tested
Ginkgo biloba
Keywords
vitiligo, leucoderma
Medical subject headings
Vitiligo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ginkgo bilobaDietary supplement

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

Study groups in NCT00907062
Study groupRoleWhat they receive
Gingko bilobaExperimental60 mg of Ginkgo biloba (standardized to 15 mg ginkgofavonglycosides) given 2 times per day, with food, for 12 weeks.
Receives: Dietary Supplement: Ginkgo biloba

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vitiligo European Task Force assessment form

    Measured: 12 weeks

Secondary outcomes (2)

  1. Vitiligo Area Scoring Index

    Measured: 12 weeks

  2. Health Canada - Canada Vigilence Adverse Reaction Form

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionOct 2009
  4. Study completionNov 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907062
Sponsor's protocol ID
NHPD#-137767
Other IDs
REB 23373
Status last verified
Jul 2010
First submitted
21 May 2009
Last updated
8 Jul 2010
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 12780716

  • 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.

    PubMed 21406109

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ginkgo biloba in people with Vitiligo Vulgaris, run by University of Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vitiligo European Task Force assessment form (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00907062, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2010.

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