An interventional study of Restylane Contour in Temporal Hollowing, sponsored by Galderma R&D. Completed at 15 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment
This is a randomized, no-treatment-controlled, evaluator-blinded, multi-center study to evaluate the effectiveness and safety of Restylane® Contour in correction of temple hollowing.
Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Restylane Contour
a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)
Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS)
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.
Time frame: Baseline, Month 3
Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50%
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%.
Time frame: Baseline, Month 3
Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator
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.
Time frame: Months 6, 9 and 12
The study was conducted at 15 study centers in the United States from 14 March 2023 to 11 December 2024.
| Milestone | Restylane Contour | No-treatment Control Group |
|---|---|---|
| Started | 181 | 44 |
| Safety population | 181 | 43 |
| Completed | 163 | 40 |
| Not completed | 18 | 4 |
| Withdrew: Withdrew consent | 5 | 2 |
| Withdrew: Lost to follow-up | 9 | 2 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Other-unspecified | 3 | 0 |
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.
| percentage of participants | Restylane Contour | No-treatment Control Group |
|---|---|---|
| Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) | 91.2 (86.85 to 95.47) | 9.1 (0.73 to 19.27) |
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%.
| percentage of participants | Restylane Contour |
|---|---|
| Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50% | 91.9 (87.26 to 96.55) |
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.
| percentage of participants | Restylane Contour |
|---|---|
| Month 6 | 94.6 (90.75 to 98.54) |
| Month 9 | 92.8 (88.34 to 97.29) |
| Month 12 | 91.6 (86.81 to 96.42) |
Collected over From Baseline up to 18 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Restylane Contour | 0/181 (0%) | 7/181 (3.9%) | 61/181 (33.7%) |
| No-treatment Control Group | 0/43 (0%) | 1/43 (2.3%) | 10/43 (23.3%) |
| Event | Restylane Contour | No-treatment Control Group |
|---|---|---|
| AppendicitisInfections and infestations | 1/181 | 1/43 |
| Anal fistulaGastrointestinal disorders | 0/181 | 1/43 |
| SepsisInfections and infestations | 1/181 | 0/43 |
| Diverticulitis intestinal perforatedInfections and infestations | 1/181 | 0/43 |
| Loss of consciousnessNervous system disorders | 1/181 | 0/43 |
| Facial bones fractureInjury, poisoning and procedural complications | 1/181 | 0/43 |
| Subdural haematomaInjury, poisoning and procedural complications | 1/181 | 0/43 |
| Retinal tearEye disorders | 1/181 | 0/43 |
| Back painMusculoskeletal and connective tissue disorders | 1/181 | 0/43 |
| Pulmonary embolismRespiratory, thoracic and mediastinal disorders | 1/181 | 0/43 |
| Event | Restylane Contour | No-treatment Control Group |
|---|---|---|
| HeadacheNervous system disorders | 17/181 | 2/43 |
| COVID-19Infections and infestations | 5/181 | 3/43 |
| Implant site painGeneral disorders | 12/181 | 2/43 |
| Vision blurredEye disorders | 0/181 | 2/43 |
| Tension headacheNervous system disorders | 0/181 | 1/43 |
| InfluenzaInfections and infestations | 1/181 | 1/43 |
| SinusitisInfections and infestations | 1/181 | 1/43 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/181 | 1/43 |
| AmblyopiaEye disorders | 0/181 | 1/43 |
| CataractEye disorders | 0/181 | 1/43 |
The Intention-to-Treat (ITT) population included all participants who were randomized and were analyzed according to the randomization scheme.
| Age, Continuous(years) | Restylane Contour | No-treatment Control Group | Total |
|---|---|---|---|
| Mean | 56.5 ± 10.25 | 58.1 ± 11.16 | 56.8 ± 10.43 |
| Sex: Female, Male(Participants) | Restylane Contour | No-treatment Control Group | Total |
|---|---|---|---|
| Female | 173 | 40 | 213 |
| Male | 8 | 4 | 12 |
| Ethnicity (NIH/OMB)(Participants) | Restylane Contour | No-treatment Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 37 | 11 | 48 |
| Not Hispanic or Latino | 144 | 33 | 177 |
| Unknown or Not Reported | 0 | 0 | 0 |
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Galderma R&D