Clinical trial NCT05987163: Study to Evaluate the Safety and Effectiveness of GP0116
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Skin Manifestations
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 186
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, 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).


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

Primary outcomes:
measure: To demonstrate non-inferiority of GP0116 versus a comparator control
timeFrame: At 3 months after Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Galderma Investigational Site (Site#8074)
state: California
city: Vista
country: United States
facility: Galderma Investigational Site (Site#8478)
state: California
city: Westport
country: United States
facility: Galderma Investigational Site (Site#8680)
state: Connecticut
city: Bradenton
country: United States
facility: Galderma Investigational Site (Site#8479)
state: Florida
city: Coral Gables
country: United States
facility: Galderma Investigational Site (Site#7030)
state: Florida
city: Coral Gables
country: United States
facility: Galderma Investigational Site (Site#8284)
state: Florida
city: West Palm Beach
country: United States
facility: Galderma Investigational Site (Site#8126)
state: Florida
city: Atlanta
country: United States
facility: Galderma Investigational Site (Site#7042)
state: Georgia
city: New Orleans
country: United States
facility: Galderma Investigational Site (Site#8580)
state: Louisiana
city: Chestnut Hill
country: United States
facility: Galderma Investigational Site (Site#8481)
state: Massachusetts
city: Birmingham
country: United States
facility: Galderma Investigational Site (Site#8631)
state: Michigan
city: New York
country: United States
facility: Galderma Investigational Site (Site#8658)
state: New York
city: Chapel Hill
country: United States
facility: Galderma Investigational Site (Site#8482)
state: North Carolina
city: Wilmington
country: United States
facility: Galderma Investigational Site (Site#8648)
state: North Carolina
city: Cincinnati
country: United States
facility: Galderma Investigational Site (Site#8783)
state: Ohio
city: Nashville
country: United States
facility: Galderma Investigational Site (Site#8496)
state: Tennessee
city: Spring
country: United States
facility: Galderma Investigational Site (Site#8662)
state: Texas
city: Arlington
country: United States
facility: Galderma Investigational Site (Site#7047)
state: Virginia
city: San Juan
country: Puerto Rico
facility: Galderma Investigational Site (Site#8784)
Study officials:
References: