New Dermal Filler for Lip Augmentation
- Conditions
- Lip Augmentation
- Interventions
- Device: New Dermal Filler
- Registration Number
- NCT03320824
- Lead Sponsor
- Galderma R&D
- Brief Summary
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 273
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description New Dermal Filler New Dermal Filler hyaluronic acid
- Primary Outcome Measures
Name Time Method Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) 8 weeks after last injection The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness (grades 0-5, with a higher score reflecting greater lip fullness) was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Effectiveness is defined as change from baseline at 8 weeks after last injection of New Dermal Filler or Dermal Filler (control).
- Secondary Outcome Measures
Name Time Method Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q 8, 16, 24, 32, 40, and 48 weeks Subjects' satisfaction using the validated FACE-Q scales Satisfaction with Lips and Appraisal of Lines: Lips at baseline and at Week 8, 16, 24, 32, 40, and 48 weeks after last injection based on individual questions in each questionnaire as well as the Rasch transformed total scores and the change from baseline in the Rasch transformed scores. Rasch-transformed total score (0-100) according the FACE-Q manual; the higher total score indicated greater subject satisfaction.A positive change from baseline indicates an improvement. Baseline is defined as the last observation before initial treatment takes place at the baseline visit on Day 1.
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale 16, 24, 32, 40, and 48 weeks Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler
Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) 8, 16, 24, 32, 40, and 48 weeks after last injection Based on Change from Baseline, New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold.
Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment 8, 16, 24, 32, 40, and 48 weeks Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler
Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) 8, 16, 24, 32, 40, and 48 weeks Based on Response Rates (defined as at least 1 point improvement from baseline), New Dermal Filler using WAS. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the Blinded Evaluator at defined time points, and not on a comparison to the baseline appearance. Scoring of fold severity was based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point and measured on a 6-point scale, with 0 being no wrinkle and 5 being very deep wrinkle/redundant fold. .
Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator 8, 16, 24, 32, 40, and 48 weeks Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer 8, 24, 40, and 48 weeks Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler
Trial Locations
- Locations (14)
Atlanta Dermatology, Vein & Research Center, LLC
🇺🇸Alpharetta, Georgia, United States
Maryland Dermatology, Laser, Skin & Vein Institute
🇺🇸Hunt Valley, Maryland, United States
BOYD
🇺🇸Birmingham, Michigan, United States
Aesthetic Solutions, PA
🇺🇸Chapel Hill, North Carolina, United States
Laser & Skin Surgery Center of New York
🇺🇸New York, New York, United States
SkinCare Physicians
🇺🇸Chestnut Hill, Massachusetts, United States
Art of Skin MD
🇺🇸Solana Beach, California, United States
Clinical Testing of Bevelry Hills
🇺🇸Encino, California, United States
Skin Research Institute, LLC
🇺🇸Coral Gables, Florida, United States
Brian S. Biesman, MD
🇺🇸Nashville, Tennessee, United States
Cosmetic Laser Dermatology
🇺🇸San Diego, California, United States
Research Institute of SouthEast
🇺🇸West Palm Beach, Florida, United States
Center for Advanced Clinical Research
🇺🇸Dallas, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States