A Pilot, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of IncobotulinumtoxinA Injections in the Treatment of Rosacea.
BACKGROUND: Rosacea has a variable presentation. Whereas the pathophysiology may differ, erythema, and flushing are the most consistent findings in all patients.
OBJECTIVE: To evaluate the safety and efficacy of incobotulinumtoxinA in reducing the severity of rosacea symptoms.
METHODS: Nine subjects with erythematotelangiectactic or papulopustular rosacea were randomized in 2 groups. Subjects in Group 1 (n=4) received up to a total of 20 U of incobotulinumtoxinA in the affected area (across both cheeks). Subjects in Group 2 (n=5) were injected with equal volumes of a saline solution. Rosacea Clinical Scores and subject satisfaction were evaluated at baseline and at 1, 4, 12, and 16 weeks post-treatment. At week 16, both groups were injected with incobotulinumtoxinA. Follow-up visits were performed at 1 and 4 weeks post-retreatment.
RESULTS: Patients in Group 1 exhibited reduction in the primary features of rosacea within 4 weeks of treatment with incobotulinumtoxinA. Consistent with this observation, patients in Group 2 (who had received the placebo in the first arm without significant changes to their symptoms) exhibited reductions in all of the primary and some of the secondary features upon treatment with incobotulinumtoxinA.
CONCLUSIONS: IncobotulinumtoxinA may be a safe and effective agent to reduce the severity of rosacea symptoms and increase patient satisfaction.
J Drugs Dermatol. 2017;16(6):549-554..