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Completed

NCT Number: NCT04177212

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

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.

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Key information

Conditions

Décolleté Wrinkles

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Merz Investigational Site #0490189, Bad Soden, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Radiesse

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

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

    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.

Secondary outcomes

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

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

    The percentage of responders (responder rate) was defined as >= 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 dynamic was assessed using MAS-Dynamic Scale. The MAS-Dynamic 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.

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

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

    Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The treating investigators were asked to rate their level of satisfaction with the aesthetic appearance of the participant's décolleté after treatment. The investigator responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement.

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

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

    Treatment satisfaction is defined as a rating of +3 (Very satisfied), +2 (Satisfied) or +1 (Somewhat satisfied). The participants were asked to rate their level of satisfaction with the aesthetic appearance of their décolleté after treatment. The participants responded on a 7-point scale: - 3 = very dissatisfied, - 2 = dissatisfied, - 1 = somewhat dissatisfied, 0 = neither satisfied nor dissatisfied, + 1 = somewhat satisfied, + 2 = satisfied, + 3 = very satisfied. The higher score indicated aesthetic improvement.

  4. 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)

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

    Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS-Wrinkles to assess aesthetic improvement in participants. The assessment was performed by treating investigator by live rating using standardized pre-treatment photographs for comparison. Treating investigator was asked based on their clinical experience to rate their overall impression of change of participant's décolleté wrinkles due to treatment. The investigator responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved. Higher score indicated aesthetic improvement.

  5. 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)

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

    Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). The sGAIS-wrinkles was used to assess aesthetic improvement in the participants. The assessment was performed by the participant by live rating using standardized pre-treatment photographs for comparison. The participant was asked to rate their overall impression of change of their décolleté wrinkles due to treatment. The participant responded on a 7-point scale: - 3 = very much worse, - 2 = much worse, - 1 = worse, 0 = no change, + 1 = improved, + 2 = much improved, + 3 = very much improved.

  6. Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)

    Time frame: Up to Week 52

Sponsors and collaborators

Lead sponsor

Merz Aesthetics GmbH

Industry

Collaborators

  • Merz Pharmaceuticals GmbH

Registry information

Official study title

Prospective, Multicenter, Parallel-group, Evaluator-blind, Randomized Study to Investigate the Effectiveness and Safety of MRZF111 in the Treatment of décolleté Wrinkles

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Nov 26, 2019
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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