Temporal Hollowing
Conditions
Brief summary
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.
Interventions
DEVICERestylane Contour
a sterile, biodegradable, transparent gel of nonanimal cross-linked HA (20 mg/mL) with the addition of lidocaine hydrochloride (3 mg/mL)
Sponsors
Galderma R&D
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older * Intent to undergo treatment for correction of temple hollowing
Exclusion criteria
* Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins * Known/previous allergy or hypersensitivity to local anesthetics, e.g., lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject) * Previous facial surgery (e.g., facelift) above the level of the horizontal line from subnasale that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments * Any previous aesthetic procedures or implants * Recurrent temporal headaches such as temporal tendinitis migraine. Have a history of migraines or frequent headaches, as determined by the (Treating) Investigator, that could interfere with the study safety and/or effectiveness assessments
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) | Baseline, Month 3 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50% | Baseline, Month 3 | 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%. |
| Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator | Months 6, 9 and 12 | 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. |
Countries
United States
Contacts
STUDY_DIRECTORStudy Director
Galderma R&D
Participant flow
Recruitment details
The study was conducted at 15 study centers in the United States from 14 March 2023 to 11 December 2024.
Pre-assignment details
A total of 225 participants were randomized in a 4:1 ratio to either the Restylane Contour group or the no treatment group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.8 years STANDARD_DEVIATION 10.43 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 48 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 177 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 181 | 0 / 43 |
| other Total, other adverse events | 61 / 181 | 10 / 43 |
| serious Total, serious adverse events | 7 / 181 | 1 / 43 |
Outcome results
None listed