Lip AugmentationNCT03967444
Study to Evaluate Satisfaction After Treatment With Kysse
A study testing Hyaluronic acid in people with Lip Augmentation, run by Galderma R&D at 2 sites in Canada.
Trial summary
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lip Augmentation
- What is being tested?
- Hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesCanada
- Study dates
- 29 May 2019to 18 Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed and dated informed consent to participate in the study
- Adult women and men who intend to undergo lip augmentation
Who cannot join
- Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
- Subjects with a previous implant other than HA in or near the intended treatment site
- Participation in any other clinical study within three (3) months before treatment
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse
Open-label, phase IV, post-marketing study to evaluate aesthetic improvement and satisfaction after treatment with Kysse.
- Conditions
- Lip Augmentation
- Being tested
- Hyaluronic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDevice
Also called Restylane Kysse
Injectable gel for lip augmentation
Hyaluronic acidDevice
Also called Restylane Kysse with other Restylane products
Injectable gel. Lip Augmentation and other wrinkles/folds
| Study group | Role | What they receive |
|---|---|---|
| Restylane Kysse | Other | Hyaluronic acid Receives: Device: Hyaluronic acid |
| Restylane Kysse with other HA | Other | Hyaluronic acid Receives: Device: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess Treatment With Restylane Kysse Using GAIS
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
Measured: 8 weeks after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start29 May 2019
- Primary completion18 Sep 2019
- Study completion18 Sep 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 59 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
- NCT03967444
- Sponsor's protocol ID
- 05DF1807
- Status last verified
- Feb 2021
- First submitted
- 27 May 2019
- Last updated
- 26 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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
- Post Marketing Study to Evaluate Lip Augmentation & Satisfaction With Restylane Kysse
- ClinicalTrials.gov ID
- NCT03967444
- Acronym / sponsor ID
- 05DF1807
- Conditions
- Lip Augmentation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 18 Sep 2019 (actual)
- First posted
- 30 May 2019 (actual)
- Results
- Posted 1 Mar 2021
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 and satisfaction after treatment with Kysse.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Restylane Kysse | Other | Device: Hyaluronic acidHyaluronic acid |
| Restylane Kysse with other HA | Other | Device: Hyaluronic acidHyaluronic acid |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Signed and dated informed consent to participate in the study
- Adult women and men who intend to undergo lip augmentation
Key exclusion criteria (3 listed)
- Subjects presenting with known allergy to HA (hyaluronic acid) filler or amide local anesthetics
- Subjects with a previous implant other than HA in or near the intended treatment site
- Participation in any other clinical study within three (3) months before treatment
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 |
|---|---|---|
| Hyaluronic acidAlso: Restylane KysseInjectable gel for lip augmentation | Device | Restylane Kysse |
| Hyaluronic acidAlso: Restylane Kysse with other Restylane productsInjectable gel. Lip Augmentation and other wrinkles/folds | Device | Restylane Kysse with other HA |
Primary outcome
Assess Treatment With Restylane Kysse Using GAIS
Time frame: 8 weeks after last treatment
The 5-grade Global Aesthetic Improvement Scale (GAIS) assess the appearance of the lips compared to pre-treatment. The rating is very much improved, much improved, improved, no change, or worse. Responders are those with a rating of at least improved.
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
Related trials for Lip Augmentation
Recruiting
A Study to Evaluate the Safety and Performance of Dr Korman Laboratories' Hyaluronic Acid Filler 20 mg/mL With Lidocaine for Lip Augmentation
Lip Augmentation
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
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Clinical Investigation on Lips Treated With HA-filler
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Recruiting
Evaluation of Facial HA Dermal Fillers in Real-Life Conditions
Lips Enhancement, Perioral Wrinkles
Active, not recruitingObservational study
Performance and Safety of Semical Dermal Fillers in Facial Rejuvenation
Facial Aging, Skin Rejuvenation
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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid in people with Lip Augmentation, run by Galderma R&D at 2 sites in Canada.
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 2 inclusion and 3 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 2 sites in Canada. 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 1 Mar 2021). 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 Treatment With Restylane Kysse Using GAIS (time frame: 8 weeks after last treatment). 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.