Restylane-L for Correction of Infraorbital Hollows

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

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.

Study Overview

• Status: Completed
• Conditions: Infraorbital Hollows
• Intervention / Treatment: Device: Restylane-L®

• Study Type: Interventional
• Enrollment (Actual): 333
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Galderma Research Site
    • Los Angeles, California, United States, 90069
      • Galderma Research Site
    • Redondo Beach, California, United States, 90277
      • Galderma Research Site
    • Solana Beach, California, United States, 92075
      • Galderma Research Site
  • Connecticut
    • Westport, Connecticut, United States, 06880
      • Galderma Research Site
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Galderma Research Site
    • Coral Gables, Florida, United States, 33146
      • Galderma Research Site
    • West Palm Beach, Florida, United States, 33401
      • Galderma Research Site
  • Illinois
    • Chicago, Illinois, United States, 60654
      • Galderma Research Site
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Galderma Research Site
  • New York
    • New York, New York, United States, 10021
      • Galderma Research Site
    • New York, New York, United States, 10003
      • Galderma Research Site
    • Rochester, New York, United States, 14564
      • Galderma Research Site
  • North Carolina
    • Wilmington, North Carolina, United States, 28405
      • Galderma Research Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Galderma Research Site
  • Texas
    • Spring, Texas, United States, 77388
      • Galderma Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Restylane-L Treatment; Restylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months.	Device: Restylane-L®; Intradermal injection.
No Intervention: No Treatment Control; No treatment control with optional treatment at 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Responder Rate Based on the Blinded Evaluator's Live Assessment of the Galderma Infraorbital Hollows Scale (GIHS)	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.	At 3 months after Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	At 6, 9, and 12 months after Baseline and at 3 and 6 months after optional treatment
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) Based on the Participants Live Assessment	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.	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
Percentage of Participants With At Least "Improved" on the GAIS Based on the Treating Investigator Live Assessment	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.	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

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2019
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: November 5, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Tear Trough
• Other Study ID Numbers: 43USTT1904

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes