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OpenTrials
Completed

NCT Number: NCT03320824

New Dermal Filler for Lip Augmentation

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

Completed

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Key information

Conditions

Lip Augmentation

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Testing of Bevelry Hills, Encino, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

New Dermal Filler

Device

hyaluronic acid

Device: FDA Approved Dermal Filler

Device

hyaluronic acid

Primary outcomes

  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 outcomes

  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 outcomes

  1. Evaluate All Reported Adverse Events

    Time frame: 48 weeks

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 25, 2017
Registry last updated
Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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