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
1 other identifier
interventional
333
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2019
Typical duration for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 5, 2019
CompletedFirst Posted
Study publicly available on registry
November 7, 2019
CompletedStudy Start
First participant enrolled
November 11, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 6, 2022
CompletedResults Posted
Study results publicly available
April 25, 2023
CompletedApril 25, 2023
April 1, 2023
1.2 years
November 5, 2019
February 17, 2023
April 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
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
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
Study Arms (2)
Restylane-L Treatment
EXPERIMENTALRestylane-L® injected with optional touch-up at 1 month and optional retreatment at 12 months.
No Treatment Control
NO INTERVENTIONNo treatment control with optional treatment at 12 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (16)
Galderma Research Site
Encino, California, 91436, United States
Galderma Research Site
Los Angeles, California, 90069, United States
Galderma Research Site
Redondo Beach, California, 90277, United States
Galderma Research Site
Solana Beach, California, 92075, United States
Galderma Research Site
Westport, Connecticut, 06880, United States
Galderma Research Site
Boynton Beach, Florida, 33472, United States
Galderma Research Site
Coral Gables, Florida, 33146, United States
Galderma Research Site
West Palm Beach, Florida, 33401, United States
Galderma Research Site
Chicago, Illinois, 60654, United States
Galderma Research Site
Chestnut Hill, Massachusetts, 02467, United States
Galderma Research Site
New York, New York, 10003, United States
Galderma Research Site
New York, New York, 10021, United States
Galderma Research Site
Rochester, New York, 14564, United States
Galderma Research Site
Wilmington, North Carolina, 28405, United States
Galderma Research Site
Nashville, Tennessee, 37203, United States
Galderma Research Site
Spring, Texas, 77388, United States
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- Galderma
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 5, 2019
First Posted
November 7, 2019
Study Start
November 11, 2019
Primary Completion
January 31, 2021
Study Completion
April 6, 2022
Last Updated
April 25, 2023
Results First Posted
April 25, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share