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Clinical Trials/NCT01051687
NCT01051687CompletedPhase 4

Botulinum Toxin Treatment for Localized Vitiligo

King Saud University1 site in 1 country10 target enrollmentStarted: April 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
the percentage of repigmentation in the previously depigmented patch, in form of color or size changes and folliculocentric repigmentation, of the treated and the control patches.

Study Overview

Brief Summary

Background: New light shed on the cholinergic aspects of vitiligo pathophysiology. It was found that acetylcholine concentration increased with a significantly reduced expression of acetylcholinesterase in vitiliginous patches that return to normal up on repigmentation.

Objective: The investigators will undertook this controlled, prospective pilot study to evaluate the efficacy and safety of botulinum toxin A in patients with localized vitiligo.

Methods: 10 patients with focal or segmental vitiligo will be recruited. For each patient with focal vitiligo, one or two vitiliginous patches will be treated. The other patches will be used as control. For each patient with segmental vitiligo, half of the lesion will be treated. The other half will be used as a control. Botulinum toxin will be injected. The response will be analyzed at the initial visit, two weeks and at two and six months after therapy.

Detailed Description

While performing a botulinum toxin A (BTX-A) treatment for glabellar frown lines and crow's feet of a lady who has also periocular vitiligo, we noted gradual and complete resolution of the vitiliginous patch, within few months, without adding other therapy. To test this observation, whether BTX-A lead to this repigmentation or it was a spontaneous one, we designed a controlled, prospective pilot study to evaluate the efficacy and safety of BTX-A in patients with localized vitiligo.

MATERIAL AND METHODS

Patients The study will be conducted in the dermatology clinic at King Khalid University Hospital. 10 patients with focal or segmental vitiligo will recruited to the study Data will be collected by patients interview included: patient characteristics (age, sex, age of onset of vitiligo, disease activity, presence of pruritus), medical history, previous treatment modalities including the clinical outcome of each modality. Complete physical examination and laboratory testing including: complete blood count, fasting blood sugar and thyroid autoantibodies were performed.

Injection Procedure Dilution of 1 ml of unpreserved saline per 100 U vial of BOTOX (Allergen pharmaceuticals, Irvine, CA). 2 units will injected intradermally every 1 cm2 with a 1ml syringe and 30 gauge needle. No other treatment modality will performed during the study.

Assessments For each patient with focal vitiligo, one vitiliginous patch - or two patches from different sites- will be treated. The other patches from the contra lateral site will be left untreated and used as control at the follow-up visit. For each patient with segmental vitiligo, half of the lesion will be treated. The other half will be left untreated and used as a control at the follow-up visit. The main outcome is the percentage of repigmentation in the previously depigmented patch, in form of color or size changes and folliculocentric repigmentation, of the treated and the control patches. Each patient will be assessed by the three investigators before and after injection with BTX-A. Patients will; be re-examined at 2 wk, 2 and 6 months after therapy. The outcome of each visit will be noted on a standardized sheet. Standardized photographs of the treated and control patches, including measurement, will be taken at each visit.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • focal vitiligo
  • segmental vitiligo

Exclusion Criteria

  • receiving any treatment during the last 4 weeks patient with contra indication to BTX-A

Arms & Interventions

botulinum toxin A

Active Comparator

Dilution of 1 ml of unpreserved saline per 100 U vial of BOTOX (Allergen pharmaceuticals, Irvine, CA). 2 units were injected intradermally every 1 cm2 with a 1ml syringe and 30 gauge needle.

Intervention: Botulinum toxin A (Drug)

Outcomes

Primary Outcomes

the percentage of repigmentation in the previously depigmented patch, in form of color or size changes and folliculocentric repigmentation, of the treated and the control patches.

Time Frame: Patients will be re-examined at 2 wk, 2 and 6 months after therapy.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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