To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
273
hyaluronic acid
hyaluronic acid
Clinical Testing of Bevelry Hills
Encino, California, United States
Cosmetic Laser Dermatology
San Diego, California, United States
Art of Skin MD
Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS)
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).
Time frame: 8 weeks after last injection
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
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 X weeks after last injection of New Dermal Filler.
Time frame: 16, 24, 32, 40, and 48 weeks after last injection
Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale
Based on Response Rates (defined as at least 1 point improvement from baseline) after treatment with New Dermal Filler
Time frame: 16, 24, 32, 40, and 48 weeks
Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Solana Beach, California, United States
Skin Research Institute, LLC
Coral Gables, Florida, United States
University of Miami
Miami, Florida, United States
Research Institute of SouthEast
West Palm Beach, Florida, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, United States
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, United States
BOYD
Birmingham, Michigan, United States
...and 4 more locations
Time frame: 8, 16, 24, 32, 40, and 48 weeks after last injection
Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator)
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. .
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment
Responders defined as at least "improved" (improved, much improved, very much improved) as assessed by subject, upper and lower lip combined, New Dermal Filler
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator
Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler
Time frame: 8, 24, 40, and 48 weeks
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
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.
Time frame: 8, 16, 24, 32, 40, and 48 weeks