Adults 18 to 65, female only, with Décolleté Wrinkles. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Responder Rate for Décolleté Wrinkles According to the Merz Aesthetics Scale (MAS)-At Rest Scale as Assessed by the Blinded Live RaterPrimary· 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.
Group
Value
95% CI
Group A: MRZF111 (3 Injections)
71.8
56.2 – 83.5
Group B: MRZF111 (2 Injections)
83.7
71.0 – 91.5
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
73.5
62.8 – 82.5
Responder Rate for Décolleté Wrinkles According to the MAS-Dynamic Scale as Assessed by the Blinded Live Rater (Last Observation Carried Forward [LOCF])Secondary· 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.
Group
Value
95% CI
Group A: MRZF111 (3 Injections)
74.4
58.9 – 85.4
Group B: MRZF111 (2 Injections)
69.4
55.5 – 80.5
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
65.8
56.8 – 73.8
Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Investigator's Treatment Satisfaction Assessment Scale (LOCF)Secondary· 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.
Group
Value
95% CI
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
76.9
68.5 – 83.6
Percentage of Participants With Aesthetic Improvement After the Décolleté Wrinkles Treatments Based on Participant's Treatment Satisfaction Assessment Scale (LOCF)Secondary· 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.
Group
Value
95% CI
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
70.1
61.3 – 77.6
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)Secondary· 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
Group
Value
95% CI
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
78.6
70.4 – 85.1
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)Secondary· 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.
Group
Value
95% CI
Pooled Treatment Group (Group A: MRZF111 [3 Injections] + Group B: MRZF111 [2 Injections])
66.7
57.7 – 74.6
Percentage of Participants With at Least One Treatment-related Treatment-emergent Adverse Event (TEAE)Secondary· Up to Week 52
Group
Value
95% CI
Group A: MRZF111 (3 Injections)
51.2
Group B: MRZF111 (2 Injections)
31.1
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 52.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Group A: MRZF111 (3 Injections)
Serious: 4/43 (9%)
Deaths: 0/43
Group B: MRZF111 (2 Injections)
Serious: 5/74 (7%)
Deaths: 0/74
Serious adverse events (11 terms)
Reaction
System
Group A: MRZF111 (3 Inject…
Group B: MRZF111 (2 Inject…
Ankle fracture
Injury, poisoning and procedural complications
—
—
Concussion
Injury, poisoning and procedural complications
—
—
Contusion
Injury, poisoning and procedural complications
—
—
Meniscus injury
Injury, poisoning and procedural complications
—
—
Post-traumatic neck syndrome
Injury, poisoning and procedural complications
—
—
Stress fracture
Injury, poisoning and procedural complications
—
—
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Keratoacanthoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Superficial spreading melanoma stage unspecified
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Merz Aesthetics GmbH
Last refreshed: 26 December 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04177212.