Trial Outcomes & Findings for Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing (NCT NCT05691972)
NCT ID: NCT05691972
Last Updated: 2026-05-22
Results Overview
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
225 participants
Primary outcome timeframe
Baseline, Month 3
Results posted on
2026-05-22
Participant Flow
The study was conducted at 15 study centers in the United States from 14 March 2023 to 11 December 2024.
A total of 225 participants were randomized in a 4:1 ratio to either the Restylane Contour group or the no treatment group.
Participant milestones
| Measure |
Restylane Contour
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Overall Study
STARTED
|
181
|
44
|
|
Overall Study
Safety Population
|
181
|
43
|
|
Overall Study
COMPLETED
|
163
|
40
|
|
Overall Study
NOT COMPLETED
|
18
|
4
|
Reasons for withdrawal
| Measure |
Restylane Contour
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Overall Study
Withdrew consent
|
5
|
2
|
|
Overall Study
Lost to Follow-up
|
9
|
2
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Other-unspecified
|
3
|
0
|
Baseline Characteristics
Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
Baseline characteristics by cohort
| Measure |
Restylane Contour
n=181 Participants
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
n=44 Participants
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
Total
n=225 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.5 years
STANDARD_DEVIATION 10.25 • n=2 Participants
|
58.1 years
STANDARD_DEVIATION 11.16 • n=4 Participants
|
56.8 years
STANDARD_DEVIATION 10.43 • n=6 Participants
|
|
Sex: Female, Male
Female
|
173 Participants
n=2 Participants
|
40 Participants
n=4 Participants
|
213 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=2 Participants
|
4 Participants
n=4 Participants
|
12 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
37 Participants
n=2 Participants
|
11 Participants
n=4 Participants
|
48 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
144 Participants
n=2 Participants
|
33 Participants
n=4 Participants
|
177 Participants
n=6 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=2 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 3Population: Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme.
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% confidence interval (CI) were calculated using the normal approximation (Wald) method.
Outcome measures
| Measure |
Restylane Contour
n=181 Participants
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
n=44 Participants
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS)
|
91.2 percentage of participants
Interval 86.85 to 95.47
|
9.1 percentage of participants
Interval 0.73 to 19.27
|
SECONDARY outcome
Timeframe: Baseline, Month 3Population: Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme. Here, 'overall number of participants analyzed' = number of participants with available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the Restylane Contour group only.
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by blinded evaluator at Month 3, compared with a reference standard responder rate of 50%.
Outcome measures
| Measure |
Restylane Contour
n=173 Participants
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50%
|
91.9 percentage of participants
Interval 87.26 to 96.55
|
—
|
SECONDARY outcome
Timeframe: Months 6, 9 and 12Population: Analysis was performed on the ITT population. The ITT population included all participants who were randomized and were analyzed according to the randomization scheme. Here, 'number analyzed' = number of participants with available data for this outcome measure. Data for this outcome measure was planned to be analyzed for the Restylane Contour group only.
Responder rate was defined as the percentage of participants with at least a 1-grade improvement from baseline based on the GTVDS in both temples concurrently, as assessed by the Blinded Evaluator. The GTVDS is a 4-grade (ranging from 0 to 3) photographically based clinical outcome instrument specifically designed to measure volume deficit in the temporal areas of the face, where 0 = none, 1 = mild, 2 = moderate, and 3 = severe volume deficit. A higher score indicated a severe outcome. Here, 97.5% CI were calculated using the normal approximation (Wald) method. Responder rate based on the GTVDS, as assessed by a blinded evaluator at Months 6, 9 and 12 are reported here.
Outcome measures
| Measure |
Restylane Contour
n=181 Participants
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator
Month 6
|
94.6 percentage of participants
Interval 90.75 to 98.54
|
—
|
|
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator
Month 9
|
92.8 percentage of participants
Interval 88.34 to 97.29
|
—
|
|
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator
Month 12
|
91.6 percentage of participants
Interval 86.81 to 96.42
|
—
|
Adverse Events
Restylane Contour
Serious events: 7 serious events
Other events: 61 other events
Deaths: 0 deaths
No-treatment Control Group
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane Contour
n=181 participants at risk
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
n=43 participants at risk
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Infections and infestations
Sepsis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Appendicitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Loss of consciousness
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Eye disorders
Retinal tear
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Cardiac disorders
Coronary artery disease
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
Other adverse events
| Measure |
Restylane Contour
n=181 participants at risk
Participants received Restylane Contour in the temple area via a needle for supraperiosteal and a needle or cannula for subdermal (superficial) injections, as determined by the Investigator at baseline (Study Day 1). An optional touch-up treatment was allowed after 1 month (4 weeks), if deemed necessary by the Investigator.
|
No-treatment Control Group
n=43 participants at risk
Participants randomized to the control group received no treatment. However, participants were offered optional treatment at 3 months (12 weeks) after baseline.
|
|---|---|---|
|
Nervous system disorders
Headache
|
9.4%
17/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
4.7%
2/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Aphasia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Dizziness
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Migraine
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
COVID-19
|
2.8%
5/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
7.0%
3/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Nasopharyngitis
|
1.7%
3/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Abscess limb
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Bronchitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Candida infection
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Gastroenteritis viral
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Influenza
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Sinusitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Infections and infestations
Urinary tract infection
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
General disorders
Implant site pain
|
6.6%
12/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
4.7%
2/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
General disorders
Pyrexia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
1.7%
3/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Actinic cheilitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Perioral dermatitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Vascular disorders
Hypertension
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Musculoskeletal and connective tissue disorders
Spondylitis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Burns second degree
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Muscle contusion
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Triple negative breast cancer
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Eye disorders
Dry eye
|
1.1%
2/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Eye disorders
Visual acuity reduced
|
1.1%
2/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Eye disorders
Amblyopia
|
0.00%
0/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Eye disorders
Vision blurred
|
0.00%
0/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
4.7%
2/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.1%
2/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Psychiatric disorders
Anxiety
|
1.1%
2/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Psychiatric disorders
Depression
|
1.1%
2/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Psychiatric disorders
Insomnia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Cardiac disorders
Cor pulmonale
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Cardiac disorders
Tachycardia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Gastrointestinal disorders
Diverticulum
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Hepatobiliary disorders
Hepatic lesion
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Immune system disorders
Food allergy
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Immune system disorders
Immunisation reaction
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Endocrine disorders
Hypothyroidism
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Gastrointestinal disorders
Gastritis
|
0.55%
1/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
0.00%
0/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
|
Eye disorders
Cataract
|
0.00%
0/181 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
2.3%
1/43 • From Baseline up to 18 months
The Safety Population included all participants who were treated with Restylane Contour or randomized to the no-treatment Control group and were analyzed according to the as treated principle.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place