Botulinum Toxin Treatment for Localized Vitiligo

Phase 4

Completed

• Conditions: Vitiligo
• Interventions: Drug: Botulinum toxin A

• Registration Number: NCT01051687
• Lead Sponsor: King Saud University

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.

Repigmentation in previously depigmented patch will be judge by the photograph and the measurement of lesion and compared to pre treatment status by a blinded dermatologist.

Study Timeline

• Study Start: 2009-04
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Last Update Submitted: 2010-01-15
• Study First Posted: 2010-01-18
• Last Update Posted: 2010-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• focal vitiligo
• segmental vitiligo

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
botulinum toxin A	Botulinum toxin A	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

King Khalid University Hospital; 🇸🇦 Riyadh, Saudi Arabia