A Study of NT 201 Doses in the Treatment of Platysma Prominence (PAOLA)

Merz Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Platysma Prominence

Treatments: Drug: NT 201; Drug: NT 201 Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05773053

M602011078

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of NT 201 in adults with moderate to severe platysma prominence.

Enrollment: 73 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of four (medial and lateral, left and right) prominent platysmal bands
• Moderate to severe platysmal bands as assessed by the investigator and subject on the MAPS-D at maximum contraction

Exclusion criteria

• Any serious disease or disorder (medical or psychiatric) that could interfere with the safe completion of treatment or compromise subject safety
• Botulinum toxin treatment in the face (below the lower orbital rim), neck, or chest within the last 12 months prior to study treatment
• History of lower face surgery, neck or chest surgery, aesthetic procedures (e.g., ablative skin resurfacing, laser, chemical peel, micro-focused ultrasound, deoxycholic acid injections, micro-needling, non-surgical fat reduction procedure), and orthodontic procedures (e.g., braces) in the 12 months prior to study treatment
• Previous use of any permanent (non-biodegradable) or semi-permanent (e.g., calcium hydroxylapatite, poly-L-lactic acid, polymethyl methacrylate, etc.) facial tissue augmentation therapy, lifting sutures, permanent implants or autologous fat to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 24 months prior to study treatment
• Previous use of any hyaluronic acid based or collagen based biodegradable facial tissue augmentation therapy to the lower face (i.e., below the level of the bottom of the nose), neck, or chest within 12 months prior to study treatment
• Any medical condition that may put the subject at increased risk with exposure to botulinum toxin of any serotype, including myasthenia gravis, Lambert-Eaton-Syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
• Female of childbearing potential not using a highly effective method of birth control, planning to get pregnant, or pregnant or lactating

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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73 participants in 4 patient groups, including a placebo group

NT 201 Dose 1

Experimental group

Description:

Subjects will receive Dose 1.

Treatment:

Drug: NT 201

NT 201 Dose 2

Experimental group

Description:

Subjects will receive Dose 2.

Treatment:

Drug: NT 201

NT 201 Dose 3

Experimental group

Description:

Subjects will receive Dose 3.

Treatment:

Drug: NT 201

Placebo

Placebo Comparator group

Description:

Subjects will receive matching placebo.

Treatment:

Drug: NT 201 Placebo