Trial Outcomes & Findings for Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China (NCT NCT03282357)
NCT ID: NCT03282357
Last Updated: 2021-02-23
Results Overview
Treatment success was defined as a greater than or equal to (\>=) 1-point improvement from baseline, as assessed by a blinded evaluator wrinkle severity rating scale (WSRS) scale. WSRS is a 5 point scale with scores as Score 1: Absent; Score 2: Mild; Score 3: Moderate; Score 4: Severe; Score 5: Extreme.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
181 participants
Primary outcome timeframe
Month 6
Results posted on
2021-02-23
Participant Flow
The study was conducted at 4 investigative sites in China.
A total of 195 participants were screened, out of which 181 were randomized. Of these, 176 participants were treated and 164 participants completed the study.
Participant milestones
| Measure |
Radiesse and Restylane
Participants received split-face nasolabial fold (NLF) treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
|
|---|---|
|
Overall Study
STARTED
|
181
|
|
Overall Study
Safety Evaluation Set
|
176
|
|
Overall Study
COMPLETED
|
164
|
|
Overall Study
NOT COMPLETED
|
17
|
Reasons for withdrawal
| Measure |
Radiesse and Restylane
Participants received split-face nasolabial fold (NLF) treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
Evaluation of the Effectiveness and Safety of Radiesse for the Correction of Nasolabial Folds in China
Baseline characteristics by cohort
| Measure |
Radiesse and Restylane
n=176 Participants
Participants received split-face NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
|
|---|---|
|
Age, Continuous
|
45.6 years
STANDARD_DEVIATION 9.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Han Chinese
|
173 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race (Asian)
|
176 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
176 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type I
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type II
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type III
|
147 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type IV
|
29 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type V
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Type VI
|
0 Participants
n=5 Participants
|
|
Fitzpatrick skin type
Missing
|
0 Participants
n=5 Participants
|
|
Height
|
159.9 centimeter (cm)
STANDARD_DEVIATION 5.60 • n=5 Participants
|
|
Weight
|
56.15 kilogram (Kg)
STANDARD_DEVIATION 8.434 • n=5 Participants
|
|
Body Mass Index (BMI)
|
21.87 kilogram per square meter (kg/m^2)
STANDARD_DEVIATION 2.817 • n=5 Participants
|
PRIMARY outcome
Timeframe: Month 6Population: The per protocol set (PPS) was the subset of the full analysis set (FAS) without any major protocol deviations. The FAS was all participants randomized who received an investigational product with at least one post-baseline effectiveness assessment (WSRS, blind evaluator's Global Aesthetic Improvement Scale \[GAIS\] or participant's GAIS assessment).
Treatment success was defined as a greater than or equal to (\>=) 1-point improvement from baseline, as assessed by a blinded evaluator wrinkle severity rating scale (WSRS) scale. WSRS is a 5 point scale with scores as Score 1: Absent; Score 2: Mild; Score 3: Moderate; Score 4: Severe; Score 5: Extreme.
Outcome measures
| Measure |
Radiesse
n=171 Nasolabial fold (NLF)
All participants received NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs on Day 1. Participants received an optional touch-up injection in the same NLF at Month 1.
|
Restylane
n=171 Nasolabial fold (NLF)
All participants received NLF treatment with control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in the same NLFs at Month 1.
|
|---|---|---|
|
Percentage of NLFs With Treatment Success at Month 6
|
66.0 Percentage of successfully treated NFLs
|
72.8 Percentage of successfully treated NFLs
|
SECONDARY outcome
Timeframe: Month 6Population: The PPS was defined as the subset of the FAS without any major protocol deviations. The FAS was defined as all participants randomized and who received an investigational product with at least one post-baseline effectiveness assessment (that is WSRS, blind evaluator's GAIS or participant's GAIS assessment).
The blinded evaluator rated the current cosmetic result for each NLF according to the GAIS based on live assessments during the visit compared with photographs taken at baseline before administration of treatment on each NLF. An improvement on the GAIS was classified as "improved", "much improved", or "very much improved. The GAIS is a 7-point scale, where: +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse).
Outcome measures
| Measure |
Radiesse
n=171 Participants
All participants received NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs on Day 1. Participants received an optional touch-up injection in the same NLF at Month 1.
|
Restylane
n=171 Participants
All participants received NLF treatment with control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in the same NLFs at Month 1.
|
|---|---|---|
|
Percentage of NLFs With an Improvement in the Blinded Evaluator's GAIS Score at Month 6
|
78.4 Percentage of NLFs
|
83.3 Percentage of NLFs
|
Adverse Events
Radiesse and Restylane
Serious events: 4 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Radiesse and Restylane
n=176 participants at risk
Participants received split-face NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
|
|---|---|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.57%
1/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
Reproductive system and breast disorders
Endometrial thickening
|
0.57%
1/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
Reproductive system and breast disorders
Uterine haemorrhage
|
0.57%
1/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
General disorders
Chest discomfort
|
0.57%
1/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
General disorders
Chest pain
|
0.57%
1/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.57%
1/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
Other adverse events
| Measure |
Radiesse and Restylane
n=176 participants at risk
Participants received split-face NLF treatment with study product Radiesse, subdermal injection, in one of the two NLFs and control product Restylane, subdermal injection, in the contralateral NLF on Day 1. Participants received an optional touch-up injection in one or both the NLFs at Month 1.
|
|---|---|
|
Infections and infestations
Urinary tract infection
|
9.1%
16/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
11/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.7%
10/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
General disorders
Injection site nodule
|
8.0%
14/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
6.2%
11/176 • Baseline up to Month 12
The investigator asked the participant for adverse events (AEs) systematically at each visit. The SES was used for AE assessment. The SES was defined as all participants who received an investigational product. As all participants received Radiesse in either of the two nasolabial folds and Restylane in the respective other, adverse events are reported in a combined group.
|
Additional Information
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