Safety and Efficacy Study of the Simultaneous Treatment of Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines and Crows Feet) in Subjects With Moderate to Severe Upper Facial Lines.

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and efficacy of NT 201 (active ingredient: Botulinum (neuro)toxin type A, free from complexing proteins) in the combined treatment of wrinkles in the upper face: Horizontal Forehead Lines [HFL], Glabellar Frown Lines [GFL], and Lateral Canthal Lines [LCL]). It is a prospective, randomized, double-blind, placebo-controlled, multicenter study with a placebo-control main period (MP) followed by an open-label extension period (OLEX).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA

Criteria

Inclusion Criteria:

• Outpatients (male or female) 18 years of age or older.

• Horizontal forehead lines [HFL], glabellar frown lines [GFL], and symmetrical lateral canthal lines [LCL] of moderate to severe intensity at maximum contraction.

Exclusion Criteria:

• Previous treatment with botulinum neurotoxin [BoNT] of any serotype in the face within the last 12 months before injection.

• Any facial cosmetic procedure within the last 12 months before baseline injection.

• Previous treatment with any biodegradable filler in the face within the last 12 months before injection.

• Any previous insertion of permanent material in the face (regardless of the time between previous treatment and this study).

• Any medical condition that may put the subject at increased risk with exposure to NT201.