Clinical trial NCT04177212: Investigation of the Effectiveness and Safety of MRZF111 in the Treatment of Décolleté Wrinkles
Official title: Prospective, Multicenter, Parallel-group, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of MRZF111 in the Treatment of décolleté Wrinkles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Décolleté Wrinkles
Lead sponsor: Merz North America, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Merz Pharmaceuticals GmbH
First posted: 2019-11-26
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live Rater
timeFrame: 16 weeks after the last treatment on Week 16 (at Week 32)
Secondary outcomes:
measure: Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])
timeFrame: 16 weeks after the last treatment on Week 16 (at Week 32)
measure: Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF)
timeFrame: 16 weeks after the last treatment on Week 16 (at Week 32)
measure: Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF)
timeFrame: 16 weeks after the last treatment on Week 16 (at Week 32)
measure: 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)
timeFrame: 16 weeks after the last treatment on Week 16 (at Week 32)
measure: 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)
timeFrame: 16 weeks after the last treatment on Week 16 (at Week 32)
measure: Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)
timeFrame: Up to Week 52
Other outcomes:
Locations:
city: Bad Soden
country: Germany
facility: Merz Investigational Site #0490189
city: Drensteinfurt
country: Germany
facility: Merz Investigational Site #0490375
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490095
city: Hamburg
country: Germany
facility: Merz Investigational Site #0490345
city: Kassel
country: Germany
facility: Merz Investigational Site #0490309
city: München
country: Germany
facility: Merz Investigational Site #0490371
city: München
country: Germany
facility: Merz Investigational Site #0490372
city: Potsdam
country: Germany
facility: Merz Investigational Site #0490362
city: Wuppertal
country: Germany
facility: Merz Investigational Site #0490367
Study officials:
affiliation: Merz North America, Inc.
name: Merz Medical Expert
role: STUDY_DIRECTOR
References: