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.

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

— ULTRA II  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622254
• Other study ID #: M602011070
• Secondary ID: 2019-004113-13
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2020
• Est. completion date: July 8, 2022

Study information

• Verified date: July 2022
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: July 8, 2022
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• NT 201
Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
• Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Locations

Country	Name	City	State
Germany	Hautmedizin BadSoden, Merz Investigational Site #0490189	Bad Soden
Germany	Privatpraxis fürr Dermatologie und Ästhetische Medizin, Merz Investigational Site #0490306	Berlin
Germany	Hautarztpraxis Dr. Niesmann & Dr. Othlinghaus, Merz Investigational Site #0490314	Bochum
Germany	Praxis für Hautkrankheiten, Merz Investigational Site #0490375	Drensteinfurt
Germany	Dermatology Dr. Hilton & Partner, Merz Investigational Site #0490381	Düsseldorf
Germany	Derma Science, Merz Investigational Site #0490345	Hamburg
Germany	Universität Hamburg, Institut Für Biologie Und Molekularbiologie, Merz Investigational Site #0490095#	Hamburg
Germany	Privatklinik Proebstle, Merz Investigational Site #0490284	Mannheim
Germany	Hautarztpraxis München-Neuhausen, Merz Investigational Site #0490372	München
Germany	Privatpraxis für Dermatologie und Ästhetik, Merz Investigational Site #0490371	München
Germany	Haut- und Lasercentrum, Merz Investigational Site #0490362	Potsdam
Germany	CentroDerm, Merz Investigational Site #0490367	Wuppertal

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Glabella Frown Line (GFL) responders at Day 30	Merz Aesthetics Scale (MAS - 5-point scale) will be used to identify responders	Day 30
Primary	Proportion of Horizontal Forehead Lines (HFL) responders at Day 30	Merz Aesthetics Scale (MAS - 5-point scale) will be used to identify responders	Day 30
Primary	Proportion of Lateral Canthal Lines (LCL) responders at Day 30	Merz Aesthetics Scale (MAS - 5-point scale) will be used to identify responders	Day 30
Secondary	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 post-baseline visits of MP	Merz Aesthetics Scale (MAS) is a 5-point scale.	Week 1, 4, 8, 12, and 16
Secondary	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 post-baseline visits of MP	Merz Aesthetics Scale (MAS) is a 5-point scale.	Week 1, 4, 8, 12, and 16
Secondary	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 post-baseline visits of MP	Merz Aesthetics Scale (MAS) is a 5-point scale.	Week 1, 4, 8, 12, and 16
Secondary	Global Aesthetic Improvement Scale (GAIS) as assessed by the subject at Day 30 of MP		Day 30
Secondary	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	Merz Aesthetics Scale (MAS) is a 5-point scale.	Day 30
Secondary	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	Merz Aesthetics Scale (MAS) is a 5-point scale.	Day 30
Secondary	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	Merz Aesthetics Scale (MAS) is a 5-point scale.	Day 30
Secondary	Global Aesthetic Improvement Scale (GAIS) as assessed by the investigator at Day 30 of MP		Day 30
Secondary	Incidence of related treatment-emergent adverse events (TEAEs) in the MP		Baseline to week 16
Secondary	Incidence of related TEAEs in the OLEX period		Week 16 to 48