Lip AugmentationNCT05342753
Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
A study testing Restylane Kysse in people with Lip Augmentation, run by Galderma R&D at 3 sites in United States.
Trial summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- Restylane Kysse
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Jun 2022to 7 Nov 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants willing to comply with the requirements of the study and providing a signed written informed consent
- Ability to adequately understand the verbal explanations and the written subject information provided in English
- Subjects seeking augmentation therapy for the lips
- Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
- Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
- Previous facial surgery, within 6 months, below the level of the lower orbital rim
- Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
- Participation in any interventional clinical study within 30 days of screening
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Galderma Research Site
Ardmore, Pennsylvania, 19003
Galderma Research Site
Los Angeles, California, 94538
Galderma Research Site
Vista, California, 92083
About this study
Official title: A Prospective Clinical Study to Evaluate Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
- Conditions
- Lip Augmentation
- Being tested
- Restylane Kysse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restylane KysseDevice
Hyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids
| Study group | Role | What they receive |
|---|---|---|
| Restylane Kysse | Experimental | Hyaluronic Acid Receives: Device: Restylane Kysse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on 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 from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Measured: At Week 8
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Measured: At Week 16
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Measured: At Week 24
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Measured: At Week 32
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Measured: At Week 40
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Measured: At Week 48
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Measured: 8 weeks after last injection (up to 12 weeks)
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Measured: 16 weeks after last injection (up to 20 weeks)
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Measured: 24 weeks after last injection (up to 28 weeks)
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Measured: 32 weeks after last injection (up to 36 weeks)
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Measured: 40 weeks after last injection (up to 44 weeks)
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Measured: 48 weeks after last injection (up to 52 weeks)
Secondary outcomes (2)
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
The WAS is a validated photograph-based outcome instrument that is designed specifically for quantifying facial folds. Scoring of fold severity is based on visual assessment of the length and apparent depth of the wrinkle at a certain time-point. Scoring of the upper perioral rhytids and oral commissures was based on visual live assessment by the investigator at defined time points; by using respective categorical scale ranging from Grade 0 to 5 where: grade 0 or 'No wrinkles', (1) 'Just perceptible wrinkle', (2) 'Shallow wrinkles', (3) 'Moderately deep wrinkle', (4) 'Deep wrinkle, well-defined edges', (5) 'Very deep wrinkle, redundant fold', higher grade represented higher fold severity. Responder was defined as a participant with at least a 1-point improvement from baseline.
Measured: At Weeks 8, 16, 24, 32, 40, and 48
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
The GAIS is a 7-point categorical scale ranging from -3 (Very Much Worse) to +3 (very much improved), used by the Treating Investigator to assess changes in the appearance of participants' lips following treatment by responding to the question: "With respect to the appearance of the participant's lips, how would you describe the result of the lip treatment compared to the photos taken before treatment?" by using the respective categorical scale as follows: Very Much Improved, Much Improved, Improved, No Change, Worse, Much Worse, Very Much Worse. In this outcome measure, percentage of participants who achieved at least 'Improved' on the GAIS assessed by treating investigator at Weeks 8, 16, 24, 32, 40, and 48 were reported.
Measured: At Weeks 8, 16, 24, 32, 40, and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start13 Jun 2022
- Primary completion25 Oct 2024
- Study completion7 Nov 2024
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.
- More trials run by Galderma R&DThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Galderma R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Galderma R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342753
- Sponsor's protocol ID
- 05DF2007
- Status last verified
- Dec 2025
- First submitted
- 16 Mar 2022
- Last updated
- 22 Dec 2025
- 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Study to Evaluate Safety and Effectiveness of Restylane® Kysse for Lip Augmentation in Chinese Subjects
- ClinicalTrials.gov ID
- NCT05342753
- Acronym / sponsor ID
- 05DF2007
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 25 Oct 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 25 Apr 2022 (actual)
- Results
- Posted 22 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement in Chinese subjects after treatment with Restylane Kysse.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Restylane Kysse | Experimental | Device: Restylane KysseHyaluronic Acid |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants willing to comply with the requirements of the study and providing a signed written informed consent
- Ability to adequately understand the verbal explanations and the written subject information provided in English
- Subjects seeking augmentation therapy for the lips
- Adult males or non-pregnant, non-breastfeeding females, 22 years of age or older with both biological parents of full Chinese descent
Key exclusion criteria (6 listed)
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram-positive bacterial proteins
- Previous use of any permanent (non-biodegradable) or semipermanent (e.g., calcium hydroxylapatite or poly-L-lactic acid) facial tissue augmentation therapy, lifting threads, permanent implants or autologous fat below the level of the lower orbital rim.
- Previous use of any HA-based or collagen-based biodegradable facial tissue augmentation therapy below the level of the lower orbital rim within 12 months prior to the baseline visit.
- Previous facial surgery, within 6 months, below the level of the lower orbital rim
- Previous surgery to the upper or lower lip, lip piercing or tattoo, or history of facial trauma.
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 |
|---|---|---|
| Restylane KysseHyaluronic Acid: Injectable gel for lip augmentation and the correction of upper perioral rhytids | Device | Restylane Kysse |
Primary outcome
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS)
Time frame: At Week 8
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Time frame: At Week 16
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Time frame: At Week 24
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Time frame: At Week 32
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Time frame: At Week 40
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on MLFS
Time frame: At Week 48
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Percentage of participants with at least 1-point improvement from baseline on MLFS are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 8 After the Last Injection
Time frame: 8 weeks after last injection (up to 12 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 16 After the Last Injection
Time frame: 16 weeks after last injection (up to 20 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 24 After the Last Injection
Time frame: 24 weeks after last injection (up to 28 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 32 After the Last Injection
Time frame: 32 weeks after last injection (up to 36 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 40 After the Last Injection
Time frame: 40 weeks after last injection (up to 44 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
Change From Baseline on the MLFS by Treatment Area at Week 48 After the Last Injection
Time frame: 48 weeks after last injection (up to 52 weeks)
The MLFS is a validated photograph-based outcome instrument that is designed specifically for quantifying lip fullness. Scoring of lip fullness from Grade 1 to 5 (grade 1: "Very Thin", grade 2: "Thin", grade 3: "Medium", grade 4: "Full" and grade 5: "Very Full"; with a higher score reflecting greater lip fullness) was based on visual live assessment by the Investigator. Improvement was defined as at least 1-point change from baseline in lip fullness. Number of participants with no improvement, one grade, two grade and three grade improvement are reported for this outcome measure.
2 secondary outcomes
Percentage of Responders With At Least "Improved" on the Wrinkle Assessment Scale (WAS)
Time frame: At Weeks 8, 16, 24, 32, 40, and 48
Percentage of Participants With At Least "Improved" on the Global Aesthetic Improvement Scale (GAIS) as Assessed by Treating Investigator at Weeks 8, 16, 24, 32, 40, and 48
Time frame: At Weeks 8, 16, 24, 32, 40, and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- 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.
Study Director study director
Galderma R&D
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restylane Kysse in people with Lip Augmentation, run by Galderma R&D at 3 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 4 inclusion and 6 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 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 22 Dec 2025). 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?
Percentage of Participants Assessed as At Least 1-point Improvement From Baseline on Medicis Lip Fullness Scale (MLFS) (time frame: At Week 8). The study lists 12 primary outcomes in all. 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 22 Dec 2025.