N/A
N=273
New Dermal Filler for Lip Augmentation
Lip Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT03320824 ↗Enrolled (actual)
273
Serious AEs
0.7%
Results posted
Jun 2020
Primary outcome: Primary: Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) — 1.8; 1.7; 1.8; 1.8 Change in MLFS score from baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- New Dermal Filler (Device); Device: FDA Approved Dermal Filler (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) |
1.8; 1.7; 1.8; 1.8 | — |
| SECONDARY Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale |
142; 129; 115; 110; 101 | — |
| SECONDARY Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale |
142; 129; 115; 110; 101 | — |
| SECONDARY Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) |
-2.2; -1.8; -1.7; -1.6; -1.5; -1.6 | — |
| SECONDARY Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) |
50; 47; 47; 47; 47; 44 | — |
| SECONDARY Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment |
170; 161; 148; 140; 131; 132 | — |
| SECONDARY Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator |
175; 169; 145; 137; 121; 114 | — |
| SECONDARY Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer |
168; 164; 149; 144; 149; 138 | — |
| SECONDARY Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q |
28.1; 83.3; 76.2; 74.9; 72.0; 69.0 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03320824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.