Lip AugmentationNCT03320824
New Dermal Filler for Lip Augmentation
A study testing New Dermal Filler and Device: FDA Approved Dermal Filler in people with Lip Augmentation, run by Galderma R&D at 14 sites in United States.
Trial summary
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- New Dermal Filler and Device: FDA Approved Dermal Filler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 14 sitesUnited States
- Study dates
- 13 Nov 2017to 23 Apr 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta, Georgia, 30022
BOYD
Birmingham, Michigan, 48009
Aesthetic Solutions, PA
Chapel Hill, North Carolina, 27517
SkinCare Physicians
Chestnut Hill, Massachusetts, 02467
Skin Research Institute, LLC
Coral Gables, Florida, 33146
Center for Advanced Clinical Research
Dallas, Texas, 75254
Clinical Testing of Bevelry Hills
Encino, California, 91436
Maryland Dermatology, Laser, Skin & Vein Institute
Hunt Valley, Maryland, 21030
University of Miami
Miami, Florida, 33136
Brian S. Biesman, MD
Nashville, Tennessee, 37203
Laser & Skin Surgery Center of New York
New York, New York, 10016
Cosmetic Laser Dermatology
San Diego, California, 92121
Art of Skin MD
Solana Beach, California, 92075
Research Institute of SouthEast
West Palm Beach, Florida, 33401
About this study
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
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
- Conditions
- Lip Augmentation
- Being tested
- New Dermal Filler, Device: FDA Approved Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Dermal FillerDevice
hyaluronic acid
Device: FDA Approved Dermal FillerDevice
hyaluronic acid
| Study group | Role | What they receive |
|---|---|---|
| New Dermal Filler | Experimental | hyaluronic acid Receives: Device: New Dermal Filler |
| Dermal Filler | Active comparator | hyaluronic acid Receives: Device: Device: FDA Approved Dermal Filler |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: 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
Measured: 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.
Measured: 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. .
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 8, 16, 24, 32, 40, and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start13 Nov 2017
- Primary completion28 Jun 2018
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lip AugmentationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320824
- Sponsor's protocol ID
- 43USK1701
- Status last verified
- Jun 2020
- First submitted
- 27 Sep 2017
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03320824
- Acronym / sponsor ID
- 43USK1701
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 28 Jun 2018 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Posted 18 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate non-inferiority of Kysse versus a control in lip fullness augmentation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Dermal Filler | Experimental | Device: New Dermal Fillerhyaluronic acid |
| Dermal Filler | Active comparator | Device: Device: FDA Approved Dermal Fillerhyaluronic acid |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New Dermal Fillerhyaluronic acid | Device | New Dermal Filler |
| Device: FDA Approved Dermal Fillerhyaluronic acid | Device | Dermal Filler |
Primary outcome
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).
8 secondary outcomes
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
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
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
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
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
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
Assessment of Improvement in Lip Fullness After New Dermal Filler Treatment, by Independent Photographic Reviewer
Time frame: 8, 24, 40, and 48 weeks
Assess Subject Satisfaction With New Dermal Filler Treatment Using the FACE-Q
Time frame: 8, 16, 24, 32, 40, and 48 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Dermal Filler and Device: FDA Approved Dermal Filler in people with Lip Augmentation, run by Galderma R&D at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess Effectiveness of the Treatment Using the Medicis Lip Fullness Scale (MLFS) (time frame: 8 weeks after last injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.