SafetyNCT03133325
A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine
A study testing GP0045 and Restylane Lyft Lidocaine in people with Safety, run by Galderma R&D at 1 site in Sweden.
Trial summary
This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine. There is a 12-week follow-up period. AEs will be recorded throughout the study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Safety
- What is being tested?
- GP0045 and Restylane Lyft Lidocaine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- 19 Apr 2017to 13 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
- Signed and dated informed consent to participate in the study, including photo consent
- Men or non-pregnant, non-breast feeding women aged 18 years or older
Who cannot join
- Known/previous allergy or hypersensitivity to any injectable HA gel
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
- Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
- Participation in any other clinical study within 30 days before treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine
This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.
There is a 12-week follow-up period. AEs will be recorded throughout the study.
- Conditions
- Safety
- Being tested
- GP0045, Restylane Lyft Lidocaine
- Keywords
- Hyaluronic Acid, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP0045Device
Hyaluronic acid gel
Restylane Lyft LidocaineDevice
Hyaluronic acid gel
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Other | Treatment with both GP0045 and Restylane Lyft Lidocaine Receives: Device: GP0045; Device: Restylane Lyft Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045
Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start19 Apr 2017
- Primary completion13 Jul 2017
- Study completion13 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 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
- NCT03133325
- Sponsor's protocol ID
- 43FE1629
- Status last verified
- Aug 2017
- First submitted
- 18 Apr 2017
- Last updated
- 25 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine
- ClinicalTrials.gov ID
- NCT03133325
- Acronym / sponsor ID
- 43FE1629
- Conditions
- Safety
- Keywords
- Hyaluronic Acid, Lidocaine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Galderma R&DIndustry (pharma, biotech, devices)
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 13 Jul 2017 (actual)
- Study completion
- 13 Jul 2017 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.
There is a 12-week follow-up period. AEs will be recorded throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Other | Device: GP0045, Device: Restylane Lyft LidocaineTreatment with both GP0045 and Restylane Lyft Lidocaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability to give consent to participate in the study
- Signed and dated informed consent to participate in the study, including photo consent
- Men or non-pregnant, non-breast feeding women aged 18 years or older
Key exclusion criteria (4 listed)
- Known/previous allergy or hypersensitivity to any injectable HA gel
- Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics
- Any condition (medical or other) that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study)
- Participation in any other clinical study within 30 days 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 |
|---|---|---|
| GP0045Hyaluronic acid gel | Device | All subjects |
| Restylane Lyft LidocaineHyaluronic acid gel | Device | All subjects |
Primary outcome
The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045
Time frame: 12 weeks
Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP0045 and Restylane Lyft Lidocaine in people with Safety, run by Galderma R&D at 1 site in Sweden.
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 4 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 25 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 1 site in Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045 (time frame: 12 weeks). 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 25 Aug 2022.