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Botulinum Toxin Treatment for Localized Vitiligo

This study has been completed.
Sponsor:
Information provided by:
King Saud University
ClinicalTrials.gov Identifier:
NCT01051687
First received: January 15, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted

January 15, 2010
January 15, 2010
April 2009
January 2010   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Botulinum Toxin Treatment for Localized Vitiligo
Botulinum Toxin Treatment for Localized Vitiligo

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Vitiligo
Drug: 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.

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.

  • No Intervention: control skin patches
    no intervention will be given to the patches
  • Active Comparator: 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.
    Intervention: Drug: Botulinum toxin A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • focal vitiligo
  • segmental vitiligo

Exclusion Criteria:

  • receiving any treatment during the last 4 weeks patient with contra indication to BTX-A
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Saudi Arabia
 
NCT01051687
09-101
Yes
Ghada Binsaif, King Saud University
King Saud University
Not Provided
Principal Investigator: Ghada Binsaif, MD King Saud University
King Saud University
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP