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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P140029 S054/ PAS001 |
| Date Original Protocol Accepted |
05/15/2026
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| Date Current Protocol Accepted |
05/15/2026
|
| Study Name |
Safety Eval Following Retreatment w Restylane
|
| Device Name |
Restylane® Contour
|
| Clinical Trial Number(s) |
NCT05691972
|
| General Study Protocol Parameters |
| Study Design |
Prospective & Retrospective Study
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| Data Source |
New Data Collection
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
A Prospective, Multicenter Study to Evaluate the Safety of Re-treatment with Restylane® Contour in the Treatment of Temple Hollowing
|
| Study Population |
Approximately 100 subjects will be enrolled and treated.
Investigation sites will be instructed to enroll subjects of race and ethnicity representative to the general population, and to include at least 10% male subjects. At least 20 subjects
will be Fitzpatrick skin type (FST) IV through VI, this includes at least 10 subjects with FST V – VI, where at least 5 subjects will be FST V and at least 5 subjects will be FST VI.
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| Sample Size |
Number of subjects: 100
Assumptions for sample size estimation: N/A
Number of sites: 8
Sites location: United States of America
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| Key Study Endpoints |
Safety Endpoints
Primary: Treatment-emergent adverse events (TEAEs) that are related to the device and/or injection procedure after the optional Month 12 re-treatment.
Effectiveness Endpoints
Secondary:
To evaluate the effectiveness of Restylane Contour in correction of temple hollowing for
the defined endpoints:
¿ Proportion of responders (subject has at least 1 grade improvement from baseline in both temples based on the Treating Investigators’ live assessment of the Galderma Temple Volume Deficit Scale [GTVDS]) at 3 and 12 months
after initial treatment and 3 months after optional Month 12 re-treatment.
¿ Proportion of subjects having at least “Improved” (improved, much improved, or very much improved) on the Global Aesthetic Improvement Scale (GAIS) on both sides of the face (each temple) as assessed by the Subject and Treating
Investigator, separately, at 3 and 12 months after initial treatment and 3 months after optional Month 12 re-treatment.
¿ Proportion of subjects in each response category for every question in the Subject Satisfaction Questionnaire (SSQ) at 3, and 12 months after initial treatment and 3 months after optional Month 12 re-treatment.
¿ Time in hours until the subject felt comfortable returning to social engagement after treatment, based on a follow-up question via telephone at 72 hours after treatment.
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| Follow-up Visits and Length of Follow-up |
Follow-up visits are planned for 3 and 12 months after initial treatment, and 3 months after optional re-treatment at Month 12.
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