Study to Investigate the Safety and Duration of Effect of Different Botulinum Toxin A (NT 201) Dose Groups Following the Treatment of Glabellar Frown Lines

Merz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Moderate to Severe Glabellar Frown Lines

Treatments: Drug: NT 201

Study type: Interventional

Funder types: Industry

Identifiers

NCT03806933

2018-002743-28 (EudraCT Number)

M602011015

Details and patient eligibility

About

The purpose of the study is to investigate the safety and duration of effect following different doses of Botulinum Toxin A (NT 201) in the treatment of glabellar frown lines (GFL).

Full description

This prospective, randomized, double-blind, multi-Center clinical study consists of a two stage experimental main period comparing different dose groups, followed by an optional open-label extension period (20 Units follow-up treatment).

Enrollment: 241 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participant 18 years or over.
• Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by investigator on the 4-point facial wrinkle scale (FWS).
• Moderate (score=2) to severe (score=3) GFL at maximum frown as assessed by participant on the 4-point FWS.

Exclusion criteria

• Previous treatment with Botulinum neurotoxin (BoNT) of any serotype in the facial area within the last 12 months before injection.
• Previous treatment with any facial cosmetic procedure (example, chemical peeling, photo rejuvenation, mesotherapy, photodynamic therapy, laser treatment, tattooing of eyebrows) in the glabellar area within the last 12 months before injection.
• Previous treatment with any biodegradable filler in the glabellar area within the last 12 months before injection.
• Inability to substantially reduce GFL by physically spreading them apart as assessed by the investigator.
• Excessively thick sebaceous skin or hypertrophic muscles in the upper third part of the face.
• Any surgery or scars in the glabellar area.
• Marked facial asymmetry.
• Eyelid ptosis.
• Marked brow ptosis and/or dermatochalasis.
• Ongoing severe or unstable medical conditions, example, systemic infection, or pulmonary disease, at the discretion of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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241 participants in 5 patient groups

NT 201 Dose group 1

Experimental group

Description:

Stage 1 and 2. Intramuscular injection into the glabellar area.

Treatment:

Drug: NT 201

NT 201 Dose group 2

Experimental group

Description:

Stage 1. Intramuscular injection into the glabellar area.

Treatment:

Drug: NT 201

NT 201 Dose group 3

Experimental group

Description:

Stage 1. Intramuscular injection into the glabellar area.

Treatment:

Drug: NT 201

NT 201 Dose group 4

Experimental group

Description:

Stage 2. Intramuscular injection into the glabellar area.

Treatment:

Drug: NT 201

NT 201 Dose group 5

Experimental group

Description:

Open Label Extension Period. Intramuscular injection into the glabellar area.

Treatment:

Drug: NT 201