Clinical trial NCT05691972: Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
Official title: A Randomized, No-treatment-controlled, Evaluator-blinded, Multi-center Study to Evaluate the Effectiveness and Safety of Restylane Contour in the Treatment of Temple Hollowing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Temporal Hollowing
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 225
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Responder rate based on the Blinded Evaluators' live assessment of the GTVDS
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Responder rates, as assessed by the Blinded Evaluator at 6, 9 and 12 months after baseline for the treatment group
timeFrame: 6,9,12 months after baseline
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Galderma Research Site
state: Arizona
city: Encino
country: United States
facility: Galderma Research Site
state: California
city: Los Angeles
country: United States
facility: Galderma Research Site
state: California
city: Redondo Beach
country: United States
facility: Galderma Research Site
state: California
city: Solana Beach
country: United States
facility: Galderma Research Site
state: California
city: Vista
country: United States
facility: Galderma Research Site
state: California
city: Washington
country: United States
facility: Galderma Research Site
state: District of Columbia
city: Adventura
country: United States
facility: Galderma Research Site
state: Florida
city: Boynton Beach
country: United States
facility: Galderma Research Site
state: Florida
city: Coral Gables
country: United States
facility: Galderma Research Site
state: Florida
city: New Orleans
country: United States
facility: Galderma Research Site
state: Louisiana
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: Chapel Hill
country: United States
facility: Galderma Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Galderma Research Site
state: North Carolina
city: Nashville
country: United States
facility: Galderma Research Site
state: Tennessee
Study officials:
affiliation: Galderma R&D
name: Study Director
role: STUDY_DIRECTOR
References: