Forehead Line Treatment With OnabotulinumtoxinA in Subjects With Forehead and Glabellar Facial Rhytids: A Phase 3...

Area of Science:

• Aesthetic medicine
• Dermatology
• Neuromodulator treatments

Background:

• Horizontal forehead lines (FHL) are a common aesthetic concern.
• Prospective Phase 3 data on FHL treatment with onabotulinumtoxinA were previously lacking.

Purpose of the Study:

• To assess the safety and efficacy of onabotulinumtoxinA for treating horizontal forehead lines (FHL) in conjunction with glabellar lines (GL).

Main Methods:

• A 12-month, Phase 3, randomized, placebo-controlled study.
• Subjects received onabotulinumtoxinA (40 U) or placebo, targeting frontalis and glabellar muscles.
• Efficacy measured by Facial Wrinkle Scale (FWS) and patient-reported outcomes.

Main Results:

• OnabotulinumtoxinA significantly improved FHL severity in 61.4% of subjects versus 0% for placebo (p < .0001).
• In subjects with psychological impact, 94.8% achieved none/mild FHL severity with onabotulinumtoxinA.
• Treatment was well-tolerated, with patient-reported outcomes aligning with clinical assessments.

Conclusions:

• OnabotulinumtoxinA (40 U) is a safe and effective treatment for moderate-to-severe horizontal forehead lines.
• The targeted injection strategy for FHL and GL demonstrated positive aesthetic outcomes.