Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles

Merz Pharmaceuticals

Status: Completed

Conditions: Décolleté Wrinkles

Treatments: Device: MRZF111

Study type: Interventional

Funder types: Industry

Identifiers

NCT04177212

M930521001

Details and patient eligibility

About

To evaluate the effectiveness and safety of MRZF111 treatment for improvement of décolleté wrinkles as assessed on the Merz Aesthetics Scales (MAS) Décolleté Wrinkles-At Rest.

Enrollment: 117 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female between ≥18 and ≤65 years old.
• Décolleté wrinkles with a rating of moderate to severe (grade 2 to 3) on the MAS Décolleté Wrinkles-At Rest as determined by the blinded live rater and confirmed by the treating investigator afterwards.

Exclusion criteria

• Any previous treatment with fat injections, poly L-lactic acid or permanent dermal fillers (e.g., silicone, polymethyl methacrylate) in the décolleté.
• Any previous surgery, including plastic surgery, or surgical permanent implant in the décolleté or in the breasts that could interfere with effectiveness and safety.
• Any previous thread lifting in the décolleté.
• Previous treatment with collagen fillers, calcium hydroxylapatite (CaHa), and/or long-lasting hyaluronic acid (HA) fillers (e.g., Belotero® Intense/Volume, Juvéderm® Volift/Volbella) in the décolleté within the past 24 months before baseline.
• Previous treatment with other HA fillers in the décolleté within the past 12 months before baseline.
• Previous treatment with botulinum toxin, ablative or fractional laser, microdermabrasion, microneedling, chemical peels and/or non-invasive skin tightening (e.g., ultrasound, radiofrequency, intense pulsed light treatment) in the décolleté within the past 6 months before baseline.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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117 participants in 2 patient groups

3 MRZF111 injection cycles

Experimental group

Description:

Enrolled subjects will receive 3 injection cycles in total at time points Day 1, Week 8, and Week 16.

Treatment:

Device: MRZF111

2 MRZF111 injection cycles

Experimental group

Description:

Enrolled subjects will receive 2 injection cycles in total at time points Day 1, and Week 16.

Treatment:

Device: MRZF111