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New Dermal Filler for Lip Augmentation

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ClinicalTrials.gov Identifier: NCT03320824
Recruitment Status : Completed
First Posted : October 25, 2017
Results First Posted : June 18, 2020
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
Q-Med AB

Study Description
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Brief Summary:
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation

Condition or disease Intervention/treatment Phase
Lip Augmentation Device: New Dermal Filler Device: Device: FDA Approved Dermal Filler Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 273 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : April 23, 2019
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) [ Time Frame: 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 :
  1. Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale [ Time Frame: 16, 24, 32, 40, and 48 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 X weeks after last injection of New Dermal Filler.

  2. Assess Effectiveness of the New Dermal Filler Treatment in the Upper & Lower Lips Using the Medicis Lip Fullness Scale [ Time Frame: 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

  3. Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Change From Baseline, Blinded Evaluator) [ Time Frame: 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.

  4. Assess Aesthetic Improvement in the Perioral Rhytids & Oral Commissures After New Dermal Filler Treatment Using the Wrinkle Assessment Scale (Response Rates, Blinded Evaluator) [ Time Frame: 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. .

  5. Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale Determined by Response Rates, Subject Assessment [ Time Frame: 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

  6. Assess Overall Aesthetic Improvement After New Dermal Filler Treatment Using the Global Aesthetic Improvement Scale, Treating Investigator [ Time Frame: 8, 16, 24, 32, 40, and 48 weeks ]
    Determined by Response Rates, Treating Investigator Assessment, New Dermal Filler

  7. Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer [ Time Frame: 8, 24, 40, and 48 weeks ]
    Proportion of Improvement (Responders) Based on Independent Photographic Reviewer Assessment by Weeks after Last Injection, New Dermal Filler

  8. Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q [ Time Frame: 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.


Other Outcome Measures:
  1. Evaluate All Reported Adverse Events [ Time Frame: 48 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03320824


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

Documents provided by Q-Med AB:
Study Protocol  [PDF] August 17, 2017
Statistical Analysis Plan  [PDF] October 25, 2018

More Information
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Responsible Party: Q-Med AB
ClinicalTrials.gov Identifier: NCT03320824    
Other Study ID Numbers: 43USK1701
First Posted: October 25, 2017    Key Record Dates
Results First Posted: June 18, 2020
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes