18 and older, any sex, with Chin Retrusion. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)Primary· At Month 6
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
Group
Value
95% CI
Restylane Defyne (Treatment Group)
81.1
72.5 – 87.9
Control (No Treatment Then Restylane Defyne)
5.4
0.7 – 18.2
Percentage of Participants (Responders) With At Least 1-Point Improvement From Baseline on the GCRS as Assessed by the Blinded Evaluator (Observed Cases)Secondary· 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 treatment
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 mon
Month 3 (after last treatment)
Group
Value
95% CI
Restylane Defyne (Treatment Group)
83.5
75.2 – 89.9
Control (No Treatment Then Restylane Defyne)
78.1
60.0 – 90.7
Month 6 (after last treatment)
Group
Value
95% CI
Restylane Defyne (Treatment Group)
84.1
75.8 – 90.5
Control (No Treatment Then Restylane Defyne)
72.7
54.5 – 86.7
Month 9 (after last treatment)
Group
Value
95% CI
Restylane Defyne (Treatment Group)
71.7
62.1 – 80.0
Control (No Treatment Then Restylane Defyne)
62.5
43.7 – 78.9
Month 12 (after last treatment)
Group
Value
95% CI
Restylane Defyne (Treatment Group)
61.1
51.3 – 70.3
Control (No Treatment Then Restylane Defyne)
68.8
50.0 – 83.9
Month 3 (after randomization)
Group
Value
95% CI
Control (No Treatment Then Restylane Defyne)
8.6
1.8 – 23.1
Percentage of Participants (Responders) With at Least 1-point Improvement From Baseline on the GCRS, as Assessed by the Treating InvestigatorSecondary· At Week 4 and Months 3, and 6
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.
At Week 4
Group
Value
95% CI
Restylane Defyne (Treatment Group)
92.8
86.3 – 96.8
Control (No Treatment Then Restylane Defyne)
0
0 – 0
At Month 3
Group
Value
95% CI
Restylane Defyne (Treatment Group)
84.4
76.2 – 90.6
Control (No Treatment Then Restylane Defyne)
0
0 – 0
At Month 6
Group
Value
95% CI
Restylane Defyne (Treatment Group)
80.4
71.6 – 87.4
Control (No Treatment Then Restylane Defyne)
0
0 – 0
Adverse events — posted to ClinicalTrials.gov
Time frame: From baseline up to 20 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Restylane Defyne (Treatment Group)
Serious: 2/111 (2%)
Deaths: 0/111
Control (No Treatment)
Serious: 1/37 (3%)
Deaths: 0/37
Control (Restylane Defyne)
Serious: 1/34 (3%)
Deaths: 0/34
Serious adverse events (4 terms)
Reaction
System
Restylane Defyne (Treatmen…
Control (No Treatment)
Control (Restylane Defyne)
Abnormal liver function
Hepatobiliary disorders
—
—
—
Cervical squamous cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
—
Uterine subserosal leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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· NA
· completed
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· NA
· completed
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· NA
· completed
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· NA
· completed
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· NA
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
Last refreshed: 12 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03597256.