ClinicalTrials.Veeva

Menu

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 (ULTRA I)

Merz Pharmaceuticals logo

Merz Pharmaceuticals

Status and phase

Completed
Phase 3

Conditions

Moderate to Severe Upper Facial Lines (Horizontal Forehead Lines, Glabellar Frown Lines, and Lateral Canthal Lines)

Treatments

Drug: Placebo
Drug: NT 201

Study type

Interventional

Funder types

Industry

Identifiers

NCT04594213
M602011071

Details and patient eligibility

About

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 (OLEX) period.

Enrollment

362 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

362 participants in 6 patient groups, including a placebo group

Main Period: Placebo (Group P)
Placebo Comparator group
Description:
Subjects will receive placebo injection in all three UFL (GFL, HFL and LCL) on Day 1 of main period.
Treatment:
Drug: Placebo
Main Period: NT 201 (Group U)
Experimental group
Description:
Subjects will receive a total of 64 Units (U) of NT 201: 20 U of NT 201 injection both in the GFL area and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 of main period.
Treatment:
Drug: NT 201
Main Period: NT 201 and Placebo (Group G and H)
Experimental group
Description:
Subjects will receive a total of 40 U of NT 201: 20 U of NT 201 injection both in the GFL and HFL area, and placebo injection in the LCL area on Day 1 of main period.
Treatment:
Drug: Placebo
Drug: NT 201
OLEX: NT 201 (Main Period: Group P)
Experimental group
Description:
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
Treatment:
Drug: NT 201
OLEX: NT 201 (Main Period: Group U)
Experimental group
Description:
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
Treatment:
Drug: NT 201
OLEX: NT 201 (Main Period: Group G and H)
Experimental group
Description:
Subjects will receive a total of 64 U of NT 201: 20 U of NT 201 injection both in the GFL and in the HFL area, and 24 U of NT 201 injection in the LCL area (12 U per side) on Day 1 (Visit 8) and Visit 13 of OLEX period.
Treatment:
Drug: NT 201

Trial documents
2

Trial contacts and locations

12

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems