Clinical trial NCT04154930: Restylane-L for Correction of Infraorbital Hollows
Official title: A Randomized, Evaluator-blinded, Parallel Group, No-treatment Controlled, Multi-center Study to Evaluate the Safety and Effectiveness of Restylane-L® for Correction of Infraorbital Hollows
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infraorbital Hollows
Keywords: Tear Trough
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2019-11-07
Enrollment: 333
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 prospective, randomized, evaluator-blinded, no-treatment controlled, parallel group, multi-center US study to evaluate the safety and effectiveness of Restylane-L® for correction of Infraorbital Hollows.


Eligibility criteria: Inclusion Criteria:

* Moderate or severe infraorbital hollows with no more than one grade difference between the left and right side at baseline as assessed by the blinded evaluator.
* Males or non-pregnant, non-breastfeeding females, over the age of 21.
* Intent to undergo correction of both orbital hollows.

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.
* Previous deep and/or superficial facial dermal therapies.
* Active or a history of recurrent or chronic infraorbital edema or rosacea or uncontrolled severe seasonal allergies.

Primary outcomes:
measure: Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)
timeFrame: At 3 months after Baseline
Secondary outcomes:
measure: Responder Rate Based on the Blinded Evaluator's Live Assessment of the GIHS at 6, 9, and 12 Months After Baseline And at 3 and 6 Months After Optional Treatment
timeFrame: At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment
measure: Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment
timeFrame: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment
measure: Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment
timeFrame: At 1, 3, 6, 9, and 12 months after randomization, at 1 month after optional touch-up, and at 1, 3 and 6 months after optional treatment
Other outcomes:
Locations:
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: Westport
country: United States
facility: Galderma Research Site
state: Connecticut
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: West Palm Beach
country: United States
facility: Galderma Research Site
state: Florida
city: Chicago
country: United States
facility: Galderma Research Site
state: Illinois
city: Chestnut Hill
country: United States
facility: Galderma Research Site
state: Massachusetts
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: New York
country: United States
facility: Galderma Research Site
state: New York
city: Rochester
country: United States
facility: Galderma Research Site
state: New York
city: Wilmington
country: United States
facility: Galderma Research Site
state: North Carolina
city: Nashville
country: United States
facility: Galderma Research Site
state: Tennessee
city: Spring
country: United States
facility: Galderma Research Site
state: Texas
Study officials:
References: