Botulinum Toxin Treatment for Localized Vitiligo

NCT01051687 | Completed Phase 4 DMC

• 1 other identifier: 09-101
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Vitiligo

Keywords

vitiligo

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

control skin patches

NO INTERVENTION

no intervention will be given to the patches

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.

Drug: Botulinum toxin A

Interventions

Botulinum toxin A DRUG

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. 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 treated. The other half will be left untreated and used as a control at the follow-up visit.

botulinum toxin A

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• focal vitiligo
• segmental vitiligo

You may not qualify if:

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

Sponsors & Collaborators

• King Saud University: lead

Study Sites (1)

King Khalid University Hospital

Riyadh, Riyadh Region, 11524, Saudi Arabia

Location

MeSH Terms

Conditions

Vitiligo

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ghada Binsaif, MD

  King Saud University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: April 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 18, 2010

Record last verified: 2010-01

Locations

SA (1)