Study to Evaluate the Safety and Effectiveness of GP0116 (NLF)
Primary Purpose
Skin Manifestations
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
GP0116
Active Comparator: FDA approved dermal filler device
Sponsored by
About this trial
This is an interventional treatment trial for Skin Manifestations
Eligibility Criteria
Inclusion Criteria: Men and non-pregnant, non-breastfeeding women aged 22 years or older. WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded Evaluator. The WSRS for each NLF does not need to be equal. Intent to undergo treatment for correction of both left and right NLF. Exclusion Criteria: Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel Known/previous allergy or hypersensitivity to local anesthetics Previous or present severe or multiple allergies manifested by severe reactions Previous facial surgery near the treatment area
Sites / Locations
- Galderma Investigational Site (Site#8126)
- Galderma Investigational Site (Site#8580)
- Galderma Investigational Site (Site#8783)
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GP0116
FDA Approved Device
Arm Description
Outcomes
Primary Outcome Measures
To demonstrate non-inferiority of GP0116 versus a comparator control
To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05987163
Brief Title
Study to Evaluate the Safety and Effectiveness of GP0116
Acronym
NLF
Official Title
A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0116 for Correction of Moderate to Severe Dynamic Facial Wrinkles and Folds, Such as Nasolabial Folds.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 12, 2023 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study in the U.S. for correction of moderate to severe dynamic facial wrinkles and folds, such as nasolabial folds (NLFs).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Manifestations
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
GP0116
Arm Type
Experimental
Arm Title
FDA Approved Device
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
GP0116
Intervention Description
GP0116 is an injectable, sterile, transparent product.
Intervention Type
Device
Intervention Name(s)
Active Comparator: FDA approved dermal filler device
Intervention Description
FDA approved dermal filler device
Primary Outcome Measure Information:
Title
To demonstrate non-inferiority of GP0116 versus a comparator control
Description
To demonstrate non-inferiority of GP0116 versus a comparator control in correction of NLFs by comparing change from baseline based on the Blinded Evaluator's live assessment of NLF correction at Month 3 using the Wrinkle Severity Rating Scale (WSRS).
Time Frame
At 3 months after Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men and non-pregnant, non-breastfeeding women aged 22 years or older.
WSRS grade of 3 or 4 (moderate to severe folds) on each NLF as assessed by the Blinded Evaluator. The WSRS for each NLF does not need to be equal.
Intent to undergo treatment for correction of both left and right NLF.
Exclusion Criteria:
Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel
Known/previous allergy or hypersensitivity to local anesthetics
Previous or present severe or multiple allergies manifested by severe reactions
Previous facial surgery near the treatment area
Facility Information:
Facility Name
Galderma Investigational Site (Site#8126)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Galderma Investigational Site (Site#8580)
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70130
Country
United States
Facility Name
Galderma Investigational Site (Site#8783)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate the Safety and Effectiveness of GP0116
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