Trial Outcomes & Findings for Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds (NCT NCT04647721)

NCT ID: NCT04647721

Last Updated: 2023-01-23

Results Overview

Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 134 participants
• Primary outcome timeframe: Baseline and Week 24 after last injection, up to 28 weeks
• Results posted on: 2023-01-23

Participant Flow

Subjects were recruited from 7 investigational sites in China.

Of the 134 enrolled, 13 subjects were exited as screen failures. This reporting group includes all randomized subjects (121).

Unit of analysis: Nasolabial Folds (NLFs)

Participant milestones

Measure	Left Side Radiesse® / Right Side Restylane® Radiesse injectable implant (dermal filler): Subdermal injection. Restylane injectable implant (dermal filler): Subdermal injection.	Left Side Restylane® / Right Side Radiesse® Radiesse injectable implant (dermal filler): Subdermal injection. Restylane injectable implant (dermal filler): Subdermal injection.
Overall Study STARTED	61 122	60 120
Overall Study Safety Population	61 122	59 118
Overall Study COMPLETED	59 118	58 116
Overall Study NOT COMPLETED	2 4	2 4

Reasons for withdrawal

Measure	Left Side Radiesse® / Right Side Restylane® Radiesse injectable implant (dermal filler): Subdermal injection. Restylane injectable implant (dermal filler): Subdermal injection.	Left Side Restylane® / Right Side Radiesse® Radiesse injectable implant (dermal filler): Subdermal injection. Restylane injectable implant (dermal filler): Subdermal injection.
Overall Study Withdrawal by Subject	0	2
Overall Study Lost to Follow-up	2	0

Baseline Characteristics

Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Moderate to Severe Nasolabial Folds

Baseline characteristics by cohort

Measure	Radiesse and Restylane n=120 Participants Subjects were randomized to receive Radiesse in either of the two nasolabial folds and Restylane in the respective other.
Age, Continuous	46.6 years STANDARD_DEVIATION 9.41 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	120 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Week 24 after last injection, up to 28 weeks

Population: This analysis population includes all randomized and treated subjects with no major protocol deviations or other events that impact analysis of the primary effectiveness endpoint (Per Protocol Set) with observed cases at the Week 24 visit.

Severity of the nasolabial folds (NLFs) was assessed and measured using the 5-point Wrinkle Severity Rating Scale (WSRS), where 1=absent and 5=extreme. A lower score indicates better outcome.

Outcome measures

Measure	Restylane n=115 NLFs Restylane injectable implant (dermal filler): Subdermal injection.	Radiesse n=115 NLFs Radiesse injectable implant (dermal filler): Subdermal injection.
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) Week 24	2.4 score on a scale Standard Deviation 0.62	2.4 score on a scale Standard Deviation 0.70
Change From Baseline to Week 24 on the Wrinkle Severity Rating Scale (WSRS) Baseline	3.4 score on a scale Standard Deviation 0.50	3.4 score on a scale Standard Deviation 0.50

SECONDARY outcome

Timeframe: Week 24 after last injection, up to 28 weeks

Population: Subjects in the Per Protocol Set with observed cases at the Week 24 visit.

The Investigator Global Aesthetic Improvement Scale is a subjective assessment where the treating physician describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). The investigator was asked to rate each NLF separately and select the rating that best applied when asked "What is the overall impression of aesthetic change of the subject's NLF due to treatment, compared to the pretreatment photograph". Improvement was defined as a rating of +1, +2, or +3. The higher the iGAIS score, the greater the improvement. Proportion refers to percentage of participants.

Outcome measures

Measure	Restylane n=114 NLFs Restylane injectable implant (dermal filler): Subdermal injection.	Radiesse n=114 NLFs Radiesse injectable implant (dermal filler): Subdermal injection.
Proportion of Subjects With Improvement on the Investigator Global Aesthetic Improvement Scale (iGAIS) for Each Nasolabial Fold (NLF) at Week 24	77.19 percentage of participants	77.19 percentage of participants

SECONDARY outcome

Timeframe: Week 24 after last injection, up to 28 weeks

Population: Subjects in the Per Protocol Set with observed cases at the Week 24 visit.

The Subject Global Aesthetic Improvement Scale is a subjective self-assessment where the subject independently describes the degree of improvement in facial appearance ranging from "Very much improved" (+3) to "Very much worse" (-3). Subjects rated each NLF separately when asked "What is the overall impression of aesthetic change of your NLF due to treatment, compared to the pretreatment photograph?" Improvement is defined as a rating of +1, +2, or +3. The higher the sGAIS score, the greater the improvement. Proportion refers to percentage of participants.

Outcome measures

Measure	Restylane n=114 NLFs Restylane injectable implant (dermal filler): Subdermal injection.	Radiesse n=114 NLFs Radiesse injectable implant (dermal filler): Subdermal injection.
Proportion of Subjects With Any Improvement on the Subject Global Aesthetic Improvement Scale (sGAIS) for Each Nasolabial Fold (NLF) at Week 24	80.70 percentage of participants	82.46 percentage of participants

SECONDARY outcome

Timeframe: Baseline to week 48 after last injection, up to 52 weeks

Population: Safety Population

Defined as AEs with onset at or after date of first administration of Radiesse. An AE was considered to be "related" if a causal relationship between Radiesse or the treatment procedure and the AE is at least reasonably possible.

Outcome measures

Measure	Restylane n=120 Participants Restylane injectable implant (dermal filler): Subdermal injection.	Radiesse Radiesse injectable implant (dermal filler): Subdermal injection.
Number of Subjects With Treatment-emergent Adverse Events (AE) Related to Radiesse	23 Participants	—

Adverse Events

Restylane

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Radiesse

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Non-NLF

Serious events: 7 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Restylane n=120 participants at risk Events affecting the NLF treated with Restylane	Radiesse n=120 participants at risk Events affecting the NLF treated with Radiesse	Non-NLF n=120 participants at risk Subjects with events not affecting either of the two NLFs
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Parathyroid tumour benign	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Thyroid cancer	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Renal and urinary disorders Ureterolithiasis	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.83% 1/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.

Other adverse events

Measure	Restylane n=120 participants at risk Events affecting the NLF treated with Restylane	Radiesse n=120 participants at risk Events affecting the NLF treated with Radiesse	Non-NLF n=120 participants at risk Subjects with events not affecting either of the two NLFs
General disorders Injection site induration	5.8% 7/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	12.5% 15/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
General disorders Injection site nodule	3.3% 4/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	10.0% 12/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.
Infections and infestations Upper respiratory tract infection	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	0.00% 0/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.	7.5% 9/120 • From first treatment up to the end of study (Week 48 after last injection), an average of 52 weeks The investigator asked the participant for adverse events (AEs) systematically at each visit. "At Risk" population for Restylane and Radiesse AEs are reported in units of NLFs; Non-NLF population is reported in units of subjects.

Additional Information

Public Disclosure Manager

Merz Aesthetics

Phone: +49 69 1503 1

Email: Aesthetic.Trials@merz.com

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