Restylane-L for Correction of Infraorbital Hollows

Not Applicable

Completed

• Conditions: Infraorbital Hollows
• Interventions: Device: Restylane-L®

• Registration Number: NCT04154930
• Lead Sponsor: Galderma R&D

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-05
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-07
• Study Start: 2019-11-11
• Primary Completion: 2021-01-31
• Study Completion: 2022-04-06
• Results First Submitted: 2023-02-17
• Status Verified: 2023-04
• Results First Submitted QC: 2023-04-21
• Last Update Submitted: 2023-04-21
• Results First Posted: 2023-04-25
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 333

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Restylane-L Treatment	Restylane-L®	Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months.

Primary Outcome Measures

Name	Time	Method
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)	At 3 months after Baseline	Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the Galderma Infraorbital Hollows Scale (GIHS), on both sides of the face, concurrently. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment	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	GAIS responder rates are based on independent assessments by the Treating Investigator. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the treating investigator to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of participant's tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.
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	At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment	Responder rate was defined as the percentage of participants with at least a 1-point improvement from baseline on the GIHS, on both sides of the face, concurrently at each of the timepoints. GIHS is a validated 4-point scale used to assess Infraorbital Hollows: 0 (none \[hollowness\]), 1 (mild \[hollowness\]), 2 (moderate \[hollowness\]), 3 (severe \[hollowness\]). Higher score means more severe (worse) hollowness in the infraorbital Hollows.
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment	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	GAIS responder rates are based on independent assessments by the participant. Responder rate was defined as the percentage of participants with at least "Improved" when compared to baseline before first treatment. The 7-graded GAIS was used by the participant to live assess the aesthetic improvement of the infraorbital hollows by responding to the question: "How would you describe the aesthetic improvement of your tear troughs today compared to the photograph taken before treatment?" by using the respective categorical scale as follows; Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse.

Trial Locations

Locations (1)

Galderma Research Site; 🇺🇸 Spring, Texas, United States