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

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

Study Overview

• Status: Completed
• Conditions: Lip Augmentation
• Intervention / Treatment: Device: New Dermal Filler; Device: Device: FDA Approved Dermal Filler

• Study Type: Interventional
• Enrollment (Actual): 273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Encino, California, United States, 91436
      • Clinical Testing of Bevelry Hills
    • San Diego, California, United States, 92121
      • Cosmetic Laser Dermatology
    • Solana Beach, California, United States, 92075
      • Art of Skin MD
  • Florida
    • Coral Gables, Florida, United States, 33146
      • Skin Research Institute, LLC
    • Miami, Florida, United States, 33136
      • University of Miami
    • West Palm Beach, Florida, United States, 33401
      • Research Institute of SouthEast
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Center, LLC
  • Maryland
    • Hunt Valley, Maryland, United States, 21030
      • Maryland Dermatology, Laser, Skin & Vein Institute
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • SkinCare Physicians
  • Michigan
    • Birmingham, Michigan, United States, 48009
      • BOYD
  • New York
    • New York, New York, United States, 10016
      • Laser & Skin Surgery Center of New York
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • Aesthetic Solutions, PA
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Brian S. Biesman, MD
  • Texas
    • Dallas, Texas, United States, 75254
      • Center for Advanced Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: New Dermal Filler; hyaluronic acid	Device: New Dermal Filler; hyaluronic acid
Active Comparator: Dermal Filler; hyaluronic acid	Device: Device: FDA Approved Dermal Filler; hyaluronic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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. .	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	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	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	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.	8, 16, 24, 32, 40, and 48 weeks

Other Outcome Measures

Outcome Measure	Time Frame
Evaluate All Reported Adverse Events	48 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): June 28, 2018
• Study Completion (Actual): April 23, 2019

Study Registration Dates

• First Submitted: September 27, 2017
• First Submitted That Met QC Criteria: October 20, 2017
• First Posted (Actual): October 25, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 43USK1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes