N/A
N=117
Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
Décolleté Wrinkles
Bottom Line
View on ClinicalTrials.gov: NCT04177212 ↗Enrolled (actual)
117
Serious AEs
7.7%
Results posted
Dec 2023
Primary outcome: Primary: Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater — 71.8; 83.7; 73.5 percentage of participants — p=< 0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MRZF111 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merz Aesthetics GmbH
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater |
71.8; 83.7; 73.5 | < 0.0001 sig |
| SECONDARY Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF]) |
74.4; 69.4; 65.8 | 0.0003 sig |
| SECONDARY Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF) |
76.9 | — |
| SECONDARY Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF) |
70.1 | — |
| SECONDARY 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) |
78.6 | — |
| SECONDARY 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) |
66.7 | — |
| SECONDARY Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE) |
51.2; 31.1 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04177212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.