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

NCT04177212 | Completed Results FDA Device

• 1 other identifier: M930521001
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Décolleté Wrinkles

Outcome Measures

Primary Outcomes (1)

• Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater

  The percentage of responders (responder rate) was defined as greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles from baseline to 16 weeks after last treatment as assessed by the blinded live rater. Responder rate for décolleté wrinkles at rest was assessed using MAS-at rest scale. The MAS-at rest scale included five-point scale: 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. The higher score indicated the worst outcome.

  16 weeks after the last treatment on Week 16 (at Week 32)

Secondary Outcomes (6)

• Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])

  16 weeks after the last treatment on Week 16 (at Week 32)

• Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF)

  16 weeks after the last treatment on Week 16 (at Week 32)

• Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF)

  16 weeks after the last treatment on Week 16 (at Week 32)

• Percentage of Participants With Global Aesthetic Improvement Based on the Investigator's Global Aesthetic Improvement Scale on Décolleté Wrinkles (iGAIS-Wrinkles) as Assessed by the Treating Investigator (LOCF)

  16 weeks after the last treatment on Week 16 (at Week 32)

• Percentage of Participants With Global Aesthetic Improvement Based on the Subject's Global Aesthetic Improvement Scale on Décolleté Wrinkles (sGAIS-Wrinkles) as Assessed by the Participant (LOCF)

  16 weeks after the last treatment on Week 16 (at Week 32)

Study Arms (2)

3 MRZF111 injection cycles

EXPERIMENTAL

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

Device: MRZF111

2 MRZF111 injection cycles

EXPERIMENTAL

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

Device: MRZF111

Interventions

MRZF111 DEVICE

MRZF111 kit consisting of one syringe of RADIESSE® Volume injectable implant, injection needles and additional components. Physiological saline solution (0.9% NaCl) is used to dilute Radiesse Volume by 1:2. Radiesse consists of calcium hydroxylapatite particles suspended in an aqueous-based gel carrier.

Also known as: Radiesse

2 MRZF111 injection cycles; 3 MRZF111 injection cycles

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merz Aesthetics GmbH: lead
• Merz Pharmaceuticals GmbH: collaborator

Study Sites (9)

Merz Investigational Site #0490189

Bad Soden, 65812, Germany

Location

Merz Investigational Site #0490375

Drensteinfurt, 48317, Germany

Location

Merz Investigational Site #0490095

Hamburg, 20146, Germany

Location

Merz Investigational Site #0490345

Hamburg, 22609, Germany

Location

Merz Investigational Site #0490309

Kassel, 34121, Germany

Location

Merz Investigational Site #0490371

München, 80539, Germany

Location

Merz Investigational Site #0490372

München, 80636, Germany

Location

Merz Investigational Site #0490362

Potsdam, 14467, Germany

Location

Merz Investigational Site #0490367

Wuppertal, 42287, Germany

Location

Results Point of Contact

• Title: Public Disclosure Manager
• Organization: Merz Aesthetics

Aesthetic.Trials@merz.com

+1 984-301-3095

Study Officials

• Merz Medical Expert

  Merz North America, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 26, 2019
• Study Start: December 4, 2019
• Primary Completion: November 17, 2020
• Study Completion: February 23, 2021
• Last Updated: December 26, 2023
• Results First Posted: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)