New Dermal Filler for Lip Augmentation
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
1 other identifier
interventional
273
1 country
14
Brief Summary
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 25, 2017
CompletedStudy Start
First participant enrolled
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2019
CompletedResults Posted
Study results publicly available
June 18, 2020
CompletedAugust 26, 2022
June 1, 2020
8 months
September 27, 2017
April 27, 2020
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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).
8 weeks after last injection
Secondary Outcomes (8)
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 after last injection
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
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
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
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
- +3 more secondary outcomes
Other Outcomes (1)
Evaluate All Reported Adverse Events
48 weeks
Study Arms (2)
New Dermal Filler
EXPERIMENTALhyaluronic acid
Dermal Filler
ACTIVE COMPARATORhyaluronic acid
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Galderma R&Dlead
Study Sites (14)
Clinical Testing of Bevelry Hills
Encino, California, 91436, United States
Cosmetic Laser Dermatology
San Diego, California, 92121, United States
Art of Skin MD
Solana Beach, California, 92075, United States
Skin Research Institute, LLC
Coral Gables, Florida, 33146, United States
University of Miami
Miami, Florida, 33136, United States
Research Institute of SouthEast
West Palm Beach, Florida, 33401, United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022, United States
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030, United States
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467, United States
BOYD
Birmingham, Michigan, 48009, United States
Laser & Skin Surgery Center of New York
New York, New York, 10016, United States
Aesthetic Solutions, PA
Chapel Hill, North Carolina, 27517, United States
Brian S. Biesman, MD
Nashville, Tennessee, 37203, United States
Center for Advanced Clinical Research
Dallas, Texas, 75254, United States
Results Point of Contact
- Title
- Clinical Project Manager
- Organization
- QMedAB
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 25, 2017
Study Start
November 13, 2017
Primary Completion
June 28, 2018
Study Completion
April 23, 2019
Last Updated
August 26, 2022
Results First Posted
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share