Trial Outcomes & Findings for Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles (NCT NCT05163353)

Last Updated: 2025-10-17

Results Overview

The percentage of responders (responder rate) was defined as the percentage of subjects achieving greater than or equal to (\>=) 1-point improvement on MAS décolleté wrinkles-at Rest from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-at rest scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.

Recruitment status

COMPLETED

Study phase

Target enrollment

152 participants

Primary outcome timeframe

Week 24

Results posted on

2025-10-17

Participant Flow

Subjects were recruited from 9 investigational sites in the United States.

A total of 152 subjects were enrolled and randomized in the study.

Participant milestones

Participant milestones
Measure	Treatment With Radiesse Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Overall Study STARTED	116	36
Overall Study Intent to Treat (ITT) Set	116	36
Overall Study Safety Evaluation Set (SES)	107	30
Overall Study COMPLETED	81	27
Overall Study NOT COMPLETED	35	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment With Radiesse Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	21	6
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	13	2

Baseline Characteristics

Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Radiesse n=116 Participants Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse n=36 Participants Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.	Total n=152 Participants Total of all reporting groups
Age, Continuous	53.7 years STANDARD_DEVIATION 7.05 • n=5 Participants	53.6 years STANDARD_DEVIATION 8.08 • n=7 Participants	53.6 years STANDARD_DEVIATION 7.28 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	36 Participants n=7 Participants	152 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	18 Participants n=5 Participants	7 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	98 Participants n=5 Participants	29 Participants n=7 Participants	127 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) White	105 Participants n=5 Participants	35 Participants n=7 Participants	140 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 24

Population: ITT Analysis Set.

Outcome measures

Outcome measures
Measure	Treatment With Radiesse n=116 Participants Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse n=36 Participants Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Percentage of Responders on Merz Aesthetic Scale (MAS) Décolleté Wrinkles - at Rest at Week 24	71.2 percentage of subjects Interval 61.4 to 79.4	6.3 percentage of subjects Interval 1.5 to 22.9

SECONDARY outcome

Timeframe: Week 24

Population: ITT Analysis Set.

The percentage of responders (responder rate) was defined as the percentage of subjects achieving \>= 1-point improvement on MAS décolleté wrinkles-Dynamic from baseline to Week 24 as assessed by the blinded evaluator. Responder rate was assessed using MAS-Dynamic scale, where 0 = no wrinkles, 1 = mild wrinkles, 2 = moderate wrinkles, 3 = severe wrinkles, 4 = very severe wrinkles. Higher score indicated the worse outcome. This analysis was done using multiple imputation method to impute missing values.

Outcome measures

Outcome measures
Measure	Treatment With Radiesse n=116 Participants Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse n=36 Participants Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Percentage of Responders on MAS Décolleté Wrinkles - Dynamic at Week 24	65.8 percentage of subjects Interval 55.9 to 74.5	16.0 percentage of subjects Interval 6.8 to 33.1

SECONDARY outcome

Timeframe: Week 24

Population: ITT Analysis Set. Here "overall number of subjects analyzed" were the number of subjects with data available for analysis of this outcome measure at the given time point. This outcome measure was pre-specified and analyzed for subjects receiving Radiesse treatment only.

Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Treating investigators used iGAIS, where - 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.

Outcome measures

Outcome measures
Measure	Treatment With Radiesse n=95 Participants Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Percentage of Subjects With Any Improvement on Investigator Global Aesthetic Improvement Scale (iGAIS) at Week 24	92.6 percentage of subjects	—

SECONDARY outcome

Timeframe: Week 24

Improvement is defined as a rating of +1 (Improved), +2 (Much improved) or +3 (Very much improved). Subjects used the sGAIS, where - 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.

Outcome measures

Outcome measures
Measure	Treatment With Radiesse n=95 Participants Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Percentage of Subjects With Any Improvement on Subject Global Aesthetic Improvement Scale (sGAIS) at Week 24	87.4 percentage of subjects	—

SECONDARY outcome

Timeframe: From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84)

Population: SES included all subjects treated at least once.

TEAEs are defined as AEs with onset on or after date of first administration of study treatment. Treatment related TEAEs are defined as any TEAEs related to diluted Radiesse treatment (that is, related to either injection procedure and/or device).

Outcome measures

Outcome measures
Measure	Treatment With Radiesse n=107 Participants Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse n=30 Participants Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) Related to Radiesse	16 Participants	0 Participants

Adverse Events

Treatment With Radiesse

Serious events: 2 serious events

Other events: 17 other events

Deaths: 0 deaths

Untreated Control/Delayed Treatment With Radiesse

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment With Radiesse n=116 participants at risk Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse n=36 participants at risk Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
General disorders Condition aggravated	0.86% 1/116 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.	0.00% 0/36 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.
Injury, poisoning and procedural complications Animal bite	0.86% 1/116 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.	0.00% 0/36 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.
Musculoskeletal and connective tissue disorders Hip deformity	0.86% 1/116 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.	0.00% 0/36 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.

Other adverse events

Other adverse events
Measure	Treatment With Radiesse n=116 participants at risk Subjects received three injections of diluted Radiesse using cannula in the décolleté treatment area on Day 1, Week 6, and Week 12. Subjects were eligible to receive an optional retreatment at Week 36.	Untreated Control/Delayed Treatment With Radiesse n=36 participants at risk Subjects remained untreated until Week 24 and then received three injections of diluted Radiesse using cannula in the décolleté treatment area at Week 24, Week 30, and Week 36. Subjects in this group had no option of retreatment.
Investigations Visual acuity tests abnormal	7.8% 9/116 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.	0.00% 0/36 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.
General disorders Injection site bruising	6.0% 7/116 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.	0.00% 0/36 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.
Infections and infestations COVID-19	2.6% 3/116 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.	5.6% 2/36 • From initial treatment (Day 1 for Treatment group and Week 24 for Control/Delayed treatment group) up to end of the study (up to Week 84) ITT Analysis set. The investigator reported AEs systematically at each visit.

Additional Information

Public Disclosure Manager

Merz Aesthetics

Phone: +1 984-301-3095

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of study information usually requires agreement with the sponsor. In case of justified doubts by the sponsor, the INVESTIGATOR will consider these doubts in the publication as long as the scientific neutrality is not affected.
Publication restrictions are in place

Restriction type: OTHER