Overview

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.