N/A
Completed N=225
Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
Temporal Hollowing
Source: ClinicalTrials.gov NCT05691972 ↗
Enrolled (actual)
225
Serious AEs
3.6%
Results posted
May 2026
Primary outcomePrimary: Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) — 91.2; 9.1 percentage of participants — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Responder Rate Based on the Blinded Evaluators' Live Assessment of the Galderma Temple Volume Deficit Scale (GTVDS) |
91.2; 9.1 | <0.001 sig |
| SECONDARY Responder Rate Based on GTVDS at Month 3 as Assessed by Blinded Evaluator Compared to a Reference Standard Responder Rate of 50% |
91.9 | — |
| SECONDARY Responder Rate Based on GTVDS at Months 6, 9 and 12 as Assessed by Blinded Evaluator |
94.6; 92.8; 91.6 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05691972). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.