Clinical trial NCT03320824: New Dermal Filler for Lip Augmentation
Official title: A Randomized, Controlled, Evaluator-Blinded, Multi-Center Study to Evaluate the Effectiveness and Safety of Restylane Kysse Versus a Control in the Augmentation of Soft Tissue Fullness of the Lip
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lip Augmentation
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2017-10-25
Enrollment: 273
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation


Eligibility criteria: Inclusion Criteria:

* Subjects willing to comply with the requirements of the study and providing a signed written informed consent.
* Males or non-pregnant, non-breastfeeding females, 22 years of age or older.
* Seeking augmentation therapy for the lips

Exclusion Criteria:

* Allergy of hypersensitivity to any injectable hyaluronic acid gel or to gram positive bacterial proteins.
* Allergy or hypersensitivity to lidocaine or other amide-type anesthetics, or topical anesthetics or nerve blocking agents.

Primary outcomes:
measure: Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS)
timeFrame: 8 weeks after last injection
Secondary outcomes:
measure: Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
timeFrame: 16, 24, 32, 40, and 48 weeks after last injection
measure: Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
timeFrame: 16, 24, 32, 40, and 48 weeks
measure: Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator)
timeFrame: 8, 16, 24, 32, 40, and 48 weeks after last injection
measure: Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator)
timeFrame: 8, 16, 24, 32, 40, and 48 weeks
measure: Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment
timeFrame: 8, 16, 24, 32, 40, and 48 weeks
measure: Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator
timeFrame: 8, 16, 24, 32, 40, and 48 weeks
measure: Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
timeFrame: 8, 24, 40, and 48 weeks
measure: Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
timeFrame: 8, 16, 24, 32, 40, and 48 weeks
Other outcomes:
measure: Evaluate All Reported Adverse Events
timeFrame: 48 weeks
Locations:
city: Encino
country: United States
facility: Clinical Testing of Bevelry Hills
state: California
city: San Diego
country: United States
facility: Cosmetic Laser Dermatology
state: California
city: Solana Beach
country: United States
facility: Art of Skin MD
state: California
city: Coral Gables
country: United States
facility: Skin Research Institute, LLC
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of SouthEast
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center, LLC
state: Georgia
city: Hunt Valley
country: United States
facility: Maryland Dermatology, Laser, Skin & Vein Institute
state: Maryland
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: Birmingham
country: United States
facility: BOYD
state: Michigan
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York
state: New York
city: Chapel Hill
country: United States
facility: Aesthetic Solutions, PA
state: North Carolina
city: Nashville
country: United States
facility: Brian S. Biesman, MD
state: Tennessee
city: Dallas
country: United States
facility: Center for Advanced Clinical Research
state: Texas
Study officials:
References: