Objectives: Keloid is a lesion that creates from the excessive restoration of the scar and has beauty and functional complications for patient and changes their quality of life. Today, varieties of methods are used but because of lesion recurrence, patients’ problems last. In this study, the two different doses of botulinum toxin type A, impact on the treatment of keloid lesion has been investigated.
Design: In this double blind clinical trial, (phase 3), 43 patients with keloid lesions were interfered. Patients were randomly assigned to one of two groups. The lesion was randomly divided into two portions in each patient.
Setting and conduct: Randomization based on quaternary numbers blocking was done by computer software.
Participants including major eligibility criteria: Inclusion criteria: patients with keloid, age between 12-65 years, patients consent to participate in the study with knowledge of the conditions and its implications. Exclusion criteria: sensitivity to BTX-A, pregnant and breastfeeding women
Intervention: Each patient receives botulinum toxin type A with concentration 200 units per ml with the dose of 10 or 20 units per cubic centimeter lesion in a part of the lesion. In another part of the lesion, normal saline was injected with the same volume. Injections have been done monthly to three times. Patients were evaluated 9 months after the last injection, according to the Vancouver scar scales and Results were analyzed in both groups.
Main outcome measures: according to the Vancouver scar scales: pigmentation, vascularity, height, and pliability.