A Phase 4 interventional study of Botulinum toxin A in Vitiligo, sponsored by King Saud University. Completed at 1 site in Saudi Arabia. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-01-18.
Sponsored by King Saud University · Phase 4, Interventional, and Treatment
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.
298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.
This study's enrollment of 10 is below the median of 30 across 227 interventional studies indexed under Vitiligo.
Browse Vitiligo studies →King Saud University is the lead sponsor of 164 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
no intervention will be given to the patches
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
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.
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.
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
King Saud University