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

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.

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

Population: The modified full analysis set (FAS) included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed via multiple imputation approach) was used for pooled treatment group.

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.

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

Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.

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.

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

Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.

Time frame: Up to Week 52

Population: SAS included participants who were randomized to Group A but treated according to the injection scheme of Group B due to COVID-19 pandemic measures and were analyzed in Group B. Participants who were treated only once were analyzed in Group B.

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.

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

Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.

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.

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

Population: The modified pooled FAS included participants who were treated at least once. As per the planned analysis based on protocol and SAP, this secondary effectiveness outcome measure was planned to be analyzed for the pooled treatment groups as Groups A and B comparison was not objective of this investigation, hence pooled data was reported for this secondary outcome measure.

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.

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

Population: The modified FAS included participants who were treated at least once. Here, overall number of participants analyzed signifies participants who were evaluable for this outcome measure. Modified FAS (observed cases) was used for Groups A and B. Modified FAS (missing data imputed with LOCF) was used for pooled treatment group.