Botulinum Toxin Treatment for Localized Vitiligo
Condition: Vitiligo
MeSH terms: Vitiligo
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Botulinum toxin A
Intervention type(s): Drug
Intervention description(s): 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.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vitiligo