18 and older, any sex, with Jawline Definition. 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 Responders Having At Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on Galderma Jawline Scale (GJS) at Month 3 as Assessed by Blinded EvaluatorPrimary· Baseline, Month 3
The GJS is a validated 5-point scale (ranges 0-4) for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. The Blinded Evaluator performed live assessment of the participant's left and right jawline separately. Here, a higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Group
Value
95% CI
Restylane Lyft Lidocaine
67.6
57.8 – 76.4
No-treatment Control Group
28.6
14.6 – 46.3
Percentage of Responders Having at Least a 1-Grade Improvement From Baseline on Both Jawlines Concurrently Based on GJS at Month 6, 9 and 12 as Assessed by Blinded EvaluatorSecondary· Baseline, Months 6, 9 and 12
The GJS is a validated 5-point scale for assessment of the jawline. Each score in the GJS is represented by photographic images of the scale, where 0 = none to minimal, 1 = mild, 2 = moderate, 3 = severe and 4 = very severe volume deficiency posterior to the jowl along the jawline. Here, higher score indicated more volume deficiency in the treatment area. A responder was defined as participants having at least a 1-grade improvement from baseline on both jawlines concurrently.
Month 6
Group
Value
95% CI
Restylane Lyft Lidocaine
62.2
51.9 – 71.8
No-treatment Control Group
21.9
9.3 – 40.0
Month 9
Group
Value
95% CI
Restylane Lyft Lidocaine
57.8
47.7 – 67.6
No-treatment Control Group
16.1
5.5 – 33.7
Month 12
Group
Value
95% CI
Restylane Lyft Lidocaine
49.5
39.4 – 59.6
No-treatment Control Group
19.4
7.5 – 37.5
Percentage of Participants Having at Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) on Both Jawlines Concurrently, as Assessed Live by the Treating Investigator at Months 3, 6, 9 and 12Secondary· Baseline, Months 3, 6, 9 and 12
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the
Month 3
Group
Value
95% CI
Restylane Lyft Lidocaine
99.0
94.7 – 100.0
No-treatment Control Group
0.0
0.0 – 10.6
Month 6
Group
Value
95% CI
Restylane Lyft Lidocaine
97.0
91.4 – 99.4
No-treatment Control Group
9.4
2.0 – 25.0
Month 9
Group
Value
95% CI
Restylane Lyft Lidocaine
90.2
82.7 – 95.2
No-treatment Control Group
9.7
2.0 – 25.8
Month 12
Group
Value
95% CI
Restylane Lyft Lidocaine
80.4
71.4 – 87.6
No-treatment Control Group
6.7
0.8 – 22.1
Percentage of Participants Having at Least "Improved" on the GAIS on Both Jawlines Concurrently, as Assessed Live by the Participant at Months 3, 6, 9 and 12Secondary· Baseline, Months 3, 6, 9 and 12
The 7-graded GAIS was used to live assess the aesthetic improvement of the jawline, that is, an improvement from baseline appearance before the first treatment by the Treating Investigator and the Participant, independently of each other. The participant responded to the question: "How would you describe the aesthetic improvement of the treatment area today compared to the photograph taken before treatment?" by using the categorical scale: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse and Very Much Worse. Percentage of participants having at least "Improved" on the
Month 3
Group
Value
95% CI
Restylane Lyft Lidocaine
93.1
86.4 – 97.2
No-treatment Control Group
0.0
0.0 – 10.6
Month 6
Group
Value
95% CI
Restylane Lyft Lidocaine
87.9
79.8 – 93.6
No-treatment Control Group
0.0
0.0 – 10.9
Month 9
Group
Value
95% CI
Restylane Lyft Lidocaine
80.4
71.4 – 87.6
No-treatment Control Group
0.0
0.0 – 11.2
Month 12
Group
Value
95% CI
Restylane Lyft Lidocaine
71.6
61.8 – 80.1
No-treatment Control Group
0.0
0.0 – 11.2
Adverse events — posted to ClinicalTrials.gov
Time frame: From Baseline up to 12 months after last treatment.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
NCT05262777 — Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
· NA
· completed
NCT05098457 — Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction
· NA
· withdrawn
NCT04886232 — A Prospective, Multicenter, Randomized, Comparator-controlled, Evaluator-blinded Study to Evaluate the Safety and Effect
· NA
· completed
NCT04638816 — Study to Evaluate Satisfaction After Treatment With Restylane
· NA
· completed
NCT03869450 — A Study to Evaluate Effectiveness and Safety of Hyaluronic Acid (HA) Fillers
· NA
· completed
Other Galderma R&D trials
Trials by the same sponsor.
NCT07047690 — A Study of Nemolizumab for the Treatment of Adults With Systemic Sclerosis
· Phase 2
· recruiting
NCT07344584 — A Prospective Pilot Study to Evaluate Safety and Effectiveness of GP0122 and GP0124 for Correction of Lines and Wrinkles
· NA
· not yet recruiting
NCT07186413 — A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne
· Phase 3
· recruiting
NCT07398989 — A Clinical Study to Assess Efficacy and Tolerability of a Topical Skincare Product on Adults With Mature, Crepey Skin
· Phase 4
· completed
NCT06988618 — Real-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults
· recruiting
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: 7 March 2025
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/NCT05622812.