N/A N=225 Randomized Single-blind Treatment

Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing

Temporal Hollowing

Bottom Line

View on ClinicalTrials.gov: NCT05691972 ↗

Enrolled (actual)

225

Serious AEs

3.6%

Results posted

May 2026

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Restylane Contour (Device)
Age: Adult, Older Adult · 22+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Oct 2023

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	—

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.

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

View full record on ClinicalTrials.gov →

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.