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

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• 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 (Upper Facial Lines [UFL]): 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 (score 2) to severe (score 3) intensity at maximum contraction as assessed by the investigator and subject according to Merz Aesthetics Scales [MAS].

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.