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 (ULTRA II)

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: NT 201; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04622254

2019-004113-13 (EudraCT Number)

M602011070

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: 368 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

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368 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 L)

Experimental group

Description:

Subjects will receive a total of 24 U NT 201: placebo injection both in the GFL and HFL area, and 24 U NT 201 injection in the LCL area (12 U per side) 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 L)

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