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.

A prospective, randomized, double-blind, placebo-controlled, multicenter study with an open-label extension period to investigate the efficacy and safety of NT 201 in the simultaneous treatment of upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral canthal lines)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-004113-13-DE

Enrollment

360

Registered

2020-04-30

Start date

2020-08-17

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate to severe upper facial lines (horizontal forehead lines, glabellar frown lines, and lateral canthal lines) MedDRA version: 20.0 Level: LLT Classification code 10048042 Term: Wrinkles System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 21.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0 Level: LLT Classification code 10052611 Term: Crow's fe

Interventions

Trade Name: Bocouture (100 Units) Product Name: Bocouture Product Code: NT 201 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Botulinum-Toxin Type A CAS Number: 93384-43-1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Outpatients (male or female) 18 years of age or older. • HFL, GFL, and symmetrical LCL of moderate (score 2) to severe (score 3) intensity at maximum contraction as assessed by the investigator and subject according to the Merz Aesthetics Scales. The rating of the investigator and the subject do not have to coincide as long as they are moderate or severe. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 340 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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, such as dermal filling, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, ultrasound treatment, tattooing of eyebrows. • 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 including any insertion of treads in the upper face or at cheeks (regardless of the time between previous treatment and this study). • Any medical condition that may put the subject at increased risk with exposure to NT 201, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy of simultaneous intramuscular injections of NT 201 in subjects with moderate to severe upper facial lines [UFL] in comparison to placebo. ;Secondary Objective: Efficacy and safety of simultaneous single and repeat-dose intramuscular injections of NT 201 in subjects with moderate to severe UFL.;Primary end point(s): Primary efficacy endpoints and main efficacy estimands: • Proportion of Glabellar Frown Lines (GFL) responders at day 30 • Proportion of Horizontal Forehead Lines (HFL) responders at day 30 • Proportion of Lateral Canthal Lines (LCL) responders at day 30 • Main estimands for primary efficacy endpoints describe the treatment effects of interest for the three treatment areas. For each main primary estimand, the variable attribute corresponds to the respective primary endpoint. Primary safety endpoint No primary safety endpoint was defined.;Timepoint(s) of evaluation of this end point: Primary efficacy endpoints: • Day 30	—

Measure

Time frame

Main Objective: Efficacy of simultaneous intramuscular injections of NT 201 in subjects with moderate to severe upper facial lines [UFL] in comparison to placebo. ;Secondary Objective: Efficacy and safety of simultaneous single and repeat-dose intramuscular injections of NT 201 in subjects with moderate to severe UFL.;Primary end point(s): Primary efficacy endpoints and main efficacy estimands: • Proportion of Glabellar Frown Lines (GFL) responders at day 30 • Proportion of Horizontal Forehead Lines (HFL) responders at day 30 • Proportion of Lateral Canthal Lines (LCL) responders at day 30 • Main estimands for primary efficacy endpoints describe the treatment effects of interest for the three treatment areas. For each main primary estimand, the variable attribute corresponds to the respective primary endpoint. Primary safety endpoint No primary safety endpoint was defined.;Timepoint(s) of evaluation of this end point: Primary efficacy endpoints: • Day 30

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary efficacy endpoints and main secondary efficacy estimands: • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for GFL at maximum contraction as assessed by the investigator at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for HFL at maximum contraction as assessed by the investigator at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for both left and right LCL at maximum contraction as assessed by the investigator at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for GFL at maximum contraction as assessed by the subject at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for HFL at maximum contraction as assessed by the subject at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for both left and right LCL at maximum contraction as assessed by the subject at Day 30 of MP. • Global Aesthetic Improvement Scale [GAIS] as assessed by the subject at Day 30 of MP. Further secondary efficacy endpoints: • Proportion of subjects with at least one grade improvement from baseline to Day 30 of MP on MAS for GFL at maximum contraction as assessed by the investigator • Proportion of subjects with at least one grade improvement from baseline to Day 30 of MP on MAS for HFL at maximum contraction as assessed by the investigator • Proportion of subjects with at least one grade improvement from baseline to Day 30 of MP on MAS for both left and right LCL at maximum contraction as assessed by the investigator • GAIS as assessed by the investigator at Day 30 of MP • No estimands are defined for further secondary endpoints. Secondary safety endpoints • Incidence of related treatment-emergent adverse events (TEAEs) in the MP • Incidence of related TEAEs in the OLEX period ;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints: • MAS for GFL at ma	—

Measure

Time frame

Secondary end point(s): Key secondary efficacy endpoints and main secondary efficacy estimands: • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for GFL at maximum contraction as assessed by the investigator at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for HFL at maximum contraction as assessed by the investigator at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for both left and right LCL at maximum contraction as assessed by the investigator at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for GFL at maximum contraction as assessed by the subject at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for HFL at maximum contraction as assessed by the subject at Day 30 of MP. • Proportion of subjects with a score of 0 (no) or 1 (mild) on MAS for both left and right LCL at maximum contraction as assessed by the subject at Day 30 of MP. • Global Aesthetic Improvement Scale [GAIS] as assessed by the subject at Day 30 of MP. Further secondary efficacy endpoints: • Proportion of subjects with at least one grade improvement from baseline to Day 30 of MP on MAS for GFL at maximum contraction as assessed by the investigator • Proportion of subjects with at least one grade improvement from baseline to Day 30 of MP on MAS for HFL at maximum contraction as assessed by the investigator • Proportion of subjects with at least one grade improvement from baseline to Day 30 of MP on MAS for both left and right LCL at maximum contraction as assessed by the investigator • GAIS as assessed by the investigator at Day 30 of MP • No estimands are defined for further secondary endpoints. Secondary safety endpoints • Incidence of related treatment-emergent adverse events (TEAEs) in the MP • Incidence of related TEAEs in the OLEX period ;Timepoint(s) of evaluation of this end point: Key secondary efficacy endpoints: • MAS for GFL at ma

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Countries

Germany

Contacts

Public ContactPublic Disclosure Manager

Merz Pharmaceuticals GmbH

clinicaltrials@merz.de

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026