Trial Outcomes & Findings for Restylane Defyne for Correction of Chin Retrusion (NCT NCT03597256)
NCT ID: NCT03597256
Last Updated: 2024-06-12
Results Overview
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
148 participants
Primary outcome timeframe
At Month 6
Results posted on
2024-06-12
Participant Flow
The study was conducted at 5 sites in China from 08 Oct 2018 to 09 Sep 2020.
Participant milestones
| Measure |
Restylane Defyne (Treatment Group)
Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment Then Restylane Defyne)
Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|
|
Overall Study
STARTED
|
111
|
37
|
|
Overall Study
Treated
|
111
|
34
|
|
Overall Study
COMPLETED
|
108
|
32
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Restylane Defyne (Treatment Group)
Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment Then Restylane Defyne)
Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Could not return for treatment
|
0
|
1
|
|
Overall Study
Moved from location
|
0
|
1
|
|
Overall Study
Not accepted the treatment
|
0
|
1
|
Baseline Characteristics
Restylane Defyne for Correction of Chin Retrusion
Baseline characteristics by cohort
| Measure |
Restylane Defyne (Treatment Group)
n=111 Participants
Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment Then Restylane Defyne)
n=37 Participants
Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 8.0 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
33.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
105 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Han Chinese
|
109 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Other
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Blinded Evaluator Galderma Chin Retrusion Scale
Score 1
|
39 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Blinded Evaluator Galderma Chin Retrusion Scale
Score 2
|
72 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 6Population: FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders with at least 1-point improvement from baseline on the GCRS, as measured by the blinded evaluator at Month 6 (after last treatment in treatment group, and after randomization in control group). Missing values at Month 6 are imputed using the BOCF method.
Outcome measures
| Measure |
Restylane Defyne (Treatment Group)
n=111 Participants
Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment Then Restylane Defyne)
n=37 Participants
Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|
|
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS, as Assessed by the Blinded Evaluator at Month 6 ([Baseline Observation Carried Forward] BOCF Method)
|
81.1 Percentage of participants
Interval 72.5 to 87.9
|
5.4 Percentage of participants
Interval 0.7 to 18.2
|
SECONDARY outcome
Timeframe: Treatment group: At Months 3, 6, 9, and 12 after last treatment, Control group: At Month 3 after randomization and Months 3, 6, 9 and 12 after last treatmentPopulation: FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. Here, "number of overall participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as measured by the Blinded Evaluator at 3, 6, 9 and 12 months after last treatment in Treatment group, and at 3 months after randomization, as well as 3, 6, 9 and 12 months after last treatment in Control group for observed cases.
Outcome measures
| Measure |
Restylane Defyne (Treatment Group)
n=109 Participants
Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment Then Restylane Defyne)
n=35 Participants
Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|
|
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
Month 3 (after last treatment)
|
83.5 Percentage of participants
Interval 75.2 to 89.9
|
78.1 Percentage of participants
Interval 60.0 to 90.7
|
|
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
Month 6 (after last treatment)
|
84.1 Percentage of participants
Interval 75.8 to 90.5
|
72.7 Percentage of participants
Interval 54.5 to 86.7
|
|
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
Month 9 (after last treatment)
|
71.7 Percentage of participants
Interval 62.1 to 80.0
|
62.5 Percentage of participants
Interval 43.7 to 78.9
|
|
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
Month 12 (after last treatment)
|
61.1 Percentage of participants
Interval 51.3 to 70.3
|
68.8 Percentage of participants
Interval 50.0 to 83.9
|
|
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)
Month 3 (after randomization)
|
—
|
8.6 Percentage of participants
Interval 1.8 to 23.1
|
SECONDARY outcome
Timeframe: At Week 4 and Months 3, and 6Population: FAS population included all participants who were treated with Restylane Defyne or randomized to no-treatment group. Here, "number of overall participants analyzed" signifies participants who were evaluable for this outcome measure and "number analyzed" signifies participants who were evaluable for specified timepoints.
GCRS is a validated 4-point scale to assesses the chin retrusion from no retrusion (0) to severe retrusion (3) which was described as follows; "0- No retrusion", "1- Mild retrusion", "2- Moderate retrusion", "3- Severe retrusion". Responder is defined as a participant with an improvement of at least one grade on the GCRS from baseline. Percentage of responders, defined by at least 1-point improvement from baseline on the GCRS, as assessed by the Treating Investigator at week 4, months 3 and 6.
Outcome measures
| Measure |
Restylane Defyne (Treatment Group)
n=111 Participants
Participants received an initial treatment with maximum 2 mL of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment Then Restylane Defyne)
n=36 Participants
Participants did not receive treatment at baseline but offered an initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|
|
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
At Week 4
|
92.8 Percentage of participants
Interval 86.3 to 96.8
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
At Month 3
|
84.4 Percentage of participants
Interval 76.2 to 90.6
|
0 Percentage of participants
Interval 0.0 to 0.0
|
|
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating Investigator
At Month 6
|
80.4 Percentage of participants
Interval 71.6 to 87.4
|
0 Percentage of participants
Interval 0.0 to 0.0
|
Adverse Events
Restylane Defyne (Treatment Group)
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Control (No Treatment)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Control (Restylane Defyne)
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Restylane Defyne (Treatment Group)
n=111 participants at risk
Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment)
n=37 participants at risk
Participants did not receive treatment at baseline and month 6 follow up visit.
|
Control (Restylane Defyne)
n=34 participants at risk
Participants received initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|---|
|
Hepatobiliary disorders
Abnormal liver function
|
0.00%
0/111 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
2.7%
1/37 • Number of events 1 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
0.00%
0/34 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervical squamous cell carcinoma
|
0.90%
1/111 • Number of events 1 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
0.00%
0/37 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
0.00%
0/34 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine subserosal leiomyoma
|
0.00%
0/111 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
0.00%
0/37 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
2.9%
1/34 • Number of events 1 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
|
Musculoskeletal and connective tissue disorders
Lumbar disc herniation
|
0.90%
1/111 • Number of events 1 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
0.00%
0/37 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
0.00%
0/34 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
Other adverse events
| Measure |
Restylane Defyne (Treatment Group)
n=111 participants at risk
Participants received an initial treatment with maximum 2 milliliter (mL) of Restylane Defyne on Day 1 for chin retrusion and, if other areas of the chin were treated for optimal chin augumentation, another maximum dosage of 2 mL were recommended at each treatment session, i.e., initial treatment or touch-up treatment respectively. An optional touch-up treatment of maximum 2 mL Restylane Defyne were given at 4 weeks after initial treatment if optimal chin augmentation had not been achieved.
|
Control (No Treatment)
n=37 participants at risk
Participants did not receive treatment at baseline and month 6 follow up visit.
|
Control (Restylane Defyne)
n=34 participants at risk
Participants received initial treatment with 2 mL Restylane Defyne at Month 6 follow-up visit after randomization and optional touch-up treatment at 4 Weeks after initial treatment.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
17.1%
19/111 • Number of events 22 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
10.8%
4/37 • Number of events 4 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
14.7%
5/34 • Number of events 6 • From baseline up to 20 months
Safety population included all participants who were treated with Restylane Defyne or randomized to no-treatment group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Initial publication of data from Study must be a multi-centre publication. Any subsequent publication/presentation must be sent to Sponsor for review 60 days before submission for publication/presentation to allow Sponsor to protect patentable inventions/confidential information. Site and Investigator agree to amend proposed publication/presentation, remove such confidential information from it, or postpone submission for a further 60 days/until intellectual property filings take place.
- Publication restrictions are in place
Restriction type: OTHER