Intralesional botulinum toxin type A equally effective and better tolerated than intralesional steroid in the treatment of keloids: a randomized controlled trial.

Intralesional (IL) corticosteroid therapy is a treatment for keloids. IL botulinum toxin type A (BTA) has been postulated in such an indication with controversial reports. To compare efficacy and safety of IL BTA to the IL corticosteroid therapy in treatment of keloids. Twenty-four patients with keloids were randomly divided into two equal groups: receiving IL steroid repeated every 4 weeks for six sessions (group A) and IL BTA 5 IU/cm(3) repeated every 8 weeks for three sessions (group B). Objective parameters (hardness, elevation, and redness), subjective complaints (itching, pain, and tenderness), patient satisfaction, and side effects were evaluated. There was a significant decrease in the volume of the lesions after treatment (P < 0.01), with a volume reduction of 82.7% and 79.2%, respectively, in both groups. A significant softening of lesions vs. baseline was observed (P < 0.01), with statistically significant improvement in softening in group A (P < 0.01). There was a significant decrease in height of lesions and in redness score compared with baseline (P < 0.01) with no significant difference in between both groups. All patients mentioned a significant reduction of their subjective complaints (P < 0.01) that were more significant in group B. Skin atrophy and telangiectasia were evident in three patients of group A. The efficacy and safety of the IL BTA were clearly evident in the current work from the rapid significant amelioration of the subjective complaints and the comparable significant improvement of the objective parameters as well as the volume of the keloids in comparison with the IL corticosteroids.

RCT Entities:   Population Interventions Outcomes