Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion (NCT NCT03624816)
NCT ID: NCT03624816
Last Updated: 2022-10-06
Results Overview
subjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
12 weeks after baseline
Results posted on
2022-10-06
Participant Flow
Participant milestones
| Measure |
Restylane Defyne
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
no-treatment control
|
|---|---|---|
|
Overall Study
STARTED
|
107
|
33
|
|
Overall Study
COMPLETED
|
97
|
26
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Restylane Defyne for Chin Augmentation and Correction of Chin Retrusion
Baseline characteristics by cohort
| Measure |
Restylane Defyne
n=107 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=33 Participants
no-treatment control
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 12.39 • n=93 Participants
|
44.4 years
STANDARD_DEVIATION 15.30 • n=4 Participants
|
47.4 years
STANDARD_DEVIATION 13.18 • n=27 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=93 Participants
|
30 Participants
n=4 Participants
|
125 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
85 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
107 participants
n=93 Participants
|
33 participants
n=4 Participants
|
140 participants
n=27 Participants
|
|
Fitzpatrick Skin type (FST)
FST I
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Fitzpatrick Skin type (FST)
FST II
|
27 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
|
Fitzpatrick Skin type (FST)
FST III
|
30 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Fitzpatrick Skin type (FST)
FST IV
|
24 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
32 Participants
n=27 Participants
|
|
Fitzpatrick Skin type (FST)
FST V
|
10 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
|
Fitzpatrick Skin type (FST)
FST VI
|
9 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after baselinesubjects achieving at least 1-grade improvement from baseline using the Galderma Chin Retrusion Scale (GCRS; 0=no retrusion, 1=mild retrusion, 2=moderate retrusion, 3=substantial retrusion) as assessed by blinded evaluator
Outcome measures
| Measure |
Restylane Defyne
n=107 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=33 Participants
no-treatment control
|
|---|---|---|
|
Evaluate Effectiveness of the Treatment Using the Galderma Chin Restrusion Scale
|
87 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 weeks after last injectionPopulation: ITT Population; NOTE: Of the 140 subjects enrolled, 1 subject was randomized but did not complete baseline FACE-Q before withdrawing consent and is, therefore, not included in this table.
Summary of change from Baseline to Week 12 in the FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). If missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population).
Outcome measures
| Measure |
Restylane Defyne
n=106 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=33 Participants
no-treatment control
|
|---|---|---|
|
Evaluate Subject Satisfaction Using the FACE-Q (Baseline to Week 12)
|
78.6 Rasch Transformed Score
Standard Deviation 22.14
|
35.1 Rasch Transformed Score
Standard Deviation 21.20
|
SECONDARY outcome
Timeframe: 24, 36, and 48 weeks after last injectionPopulation: ITT population
Response rates, defined by at least 1 point improvement from baseline using the Galderma Chin Retrusion Scale (GCRS), as assessed by the Blinded Evaluator, at 24,36, and 48 weeks after the last injection for the treatment group or after baseline if randomized to no treatment
Outcome measures
| Measure |
Restylane Defyne
n=101 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=31 Participants
no-treatment control
|
|---|---|---|
|
Evaluate Effectiveness of the Treatment Using the Galderma Chin Retrusion
|
87 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12, 24, 36, and 48 weeks after last injectionPopulation: ITT population
Aesthetic improvement (overall appearance) after treatment with Restylane® Defyne compared to no-treatment control, as determined by assessments using the Global Aesthetic Improvement Scale (GAIS). Assessments were performed at 12, 24, 36, and 48 weeks after treatment. Treating Investigators and subjects separately rated aesthetic improvement of the chin from baseline appearance, where a higher score reflects reporting of greater improvement. The subjects and Investigators select a score from the following categorical scale: Very much improved = 3; Much improved = 2; Improved = 1; No change = 0; Worse = -1; Much worse = -2; Very much worse = -3. Scores range from -3 (worst) to 3 (best). Higher scores reflect a better outcome. The Responder Rate is defined as the number and percent of subjects with a rating of at least "Improved" based off of subject's/investigator's (as appropriate) assessment of the GAIS.
Outcome measures
| Measure |
Restylane Defyne
n=101 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=31 Participants
no-treatment control
|
|---|---|---|
|
Assess Overall Aesthetic Improvement Using the Global Aesthetic Improvement Scale
|
100 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24, 36, and 48 weeks after last injectionPopulation: ITT population
Summary of Change from Baseline to Week 24 in FACE-Q Satisfaction with Chin, where subjects were asked about their satisfaction with treatment outcome on their chin. Higher scores reflect a better outcome. Scale consists of 10 questions and subjects select level of satisfaction for each question from/to Very dissatisfied = 1, Somewhat dissatisfied = 2, Somewhat satisfied = 3, Very satisfied = 4. A Conversion Table converts raw scale summed score into a score from 0 (worst) to 100 (best). IIf missing data is less than 50% of the scale's items, the mean of the completed items is used (Rasch Transformed Total Score: BOCF (ITT Population).
Outcome measures
| Measure |
Restylane Defyne
n=98 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=30 Participants
no-treatment control
|
|---|---|---|
|
Evaluate Subject Satisfaction Using the FACE-Q (From Baseline to Week 24)
|
75.9 FACE-Q Satisfaction with Chin Rasch Tran
Standard Deviation 21.76
|
33.2 FACE-Q Satisfaction with Chin Rasch Tran
Standard Deviation 20.77
|
SECONDARY outcome
Timeframe: 12, 24, 36, and 48 weeks after last injectionPopulation: ITT Population
Summary of Total Volume Change in the Chin Area Measured by Digital 3D Photography at Each Visit (ITT Population). Total volume change corresponds to net volume change from baseline in the chin area.
Outcome measures
| Measure |
Restylane Defyne
n=101 Participants
Injection with Restylane Defyne
Restylane Defyne: hyaluronic acid dermal filler gel
|
Control
n=31 Participants
no-treatment control
|
|---|---|---|
|
Evaluate Volume Change in the Treated Area Using 3D Imaging
Week 12
|
3.0 mL
Standard Deviation 2.61
|
-0.6 mL
Standard Deviation 1.46
|
|
Evaluate Volume Change in the Treated Area Using 3D Imaging
Week 24
|
2.5 mL
Standard Deviation 2.34
|
-0.3 mL
Standard Deviation 1.5
|
|
Evaluate Volume Change in the Treated Area Using 3D Imaging
Week 36
|
2.5 mL
Standard Deviation 2.61
|
-0.5 mL
Standard Deviation 1.45
|
|
Evaluate Volume Change in the Treated Area Using 3D Imaging
Week 48
|
2.6 mL
Standard Deviation 2.51
|
-0.5 mL
Standard Deviation 1.14
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Restylane Defyne
Serious events: 1 serious events
Other events: 65 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control
n=33 participants at risk
Subjects randomized to no treatment/control at baseline
|
Restylane Defyne
n=107 participants at risk
Subjects randomized to treatment with Restylane Defyne at baseline
Restylane Defyne: hyaluronic acid dermal filler gel
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Stage IV metastatic lung cancer
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
Other adverse events
| Measure |
Control
n=33 participants at risk
Subjects randomized to no treatment/control at baseline
|
Restylane Defyne
n=107 participants at risk
Subjects randomized to treatment with Restylane Defyne at baseline
Restylane Defyne: hyaluronic acid dermal filler gel
|
|---|---|---|
|
General disorders
Implant site pain
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
4.7%
5/107 • Number of events 7 • 1 year, 6 months
|
|
General disorders
Implant site bruising
|
0.00%
0/33 • 1 year, 6 months
|
2.8%
3/107 • Number of events 3 • 1 year, 6 months
|
|
General disorders
Implant site swelling
|
0.00%
0/33 • 1 year, 6 months
|
2.8%
3/107 • Number of events 3 • 1 year, 6 months
|
|
General disorders
Implant site erythema
|
0.00%
0/33 • 1 year, 6 months
|
1.9%
2/107 • Number of events 2 • 1 year, 6 months
|
|
General disorders
Implant site hemorrhage
|
0.00%
0/33 • 1 year, 6 months
|
1.9%
2/107 • Number of events 2 • 1 year, 6 months
|
|
General disorders
Implant site nodule
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.93%
1/107 • Number of events 2 • 1 year, 6 months
|
|
General disorders
Implant site mass
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
Implant site oedema
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
Implant site eczema
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
Tooth Infection
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
General disorders
fatigue
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
implant site cyst
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
influenza like illness
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
injection site eczema
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
nodule
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
pain
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
General disorders
pyrexia
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
cystitis
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
gastroenteritis
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
influenza
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
tonsillitis
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
oral herpes
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
tooth abscess
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
urinary tract infection
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/33 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Infections and infestations
sinusitis
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
contusion
|
0.00%
0/33 • 1 year, 6 months
|
1.9%
2/107 • Number of events 2 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
ligament sprain
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
procedural anxiety
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
procedural pain
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
skin abrasion
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Injury, poisoning and procedural complications
tooth fracture
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung cancer metastatic
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant melanoma
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
metastases to CNS
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
acne
|
0.00%
0/33 • 1 year, 6 months
|
1.9%
2/107 • Number of events 2 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
dermal cyst
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
perioral dermatitis
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Skin and subcutaneous tissue disorders
dermatitis contact
|
0.00%
0/33 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Ear and labyrinth disorders
ear discomfort
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Ear and labyrinth disorders
middle ear effusion
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Ear and labyrinth disorders
vertigo
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
food poisoning
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
GERD
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Nervous system disorders
headache
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Nervous system disorders
presyncope
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
haemoptysis
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
paranasal sinus discomfort
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 2 • 1 year, 6 months
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary mass
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Eye disorders
Meibomian gland dysfunction
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Eye disorders
glaucoma
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Hepatobiliary disorders
hepatic mass
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Immune system disorders
food allergy
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Psychiatric disorders
insomnia
|
3.0%
1/33 • Number of events 1 • 1 year, 6 months
|
0.00%
0/107 • 1 year, 6 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • 1 year, 6 months
|
0.93%
1/107 • Number of events 1 • 1 year, 6 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/33 • 1 year, 6 months
|
1.9%
2/107 • Number of events 2 • 1 year, 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
- Publication restrictions are in place
Restriction type: OTHER