Safety
Conditions
Keywords
Hyaluronic Acid, Lidocaine
Brief 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.
Interventions
DEVICEGP0045
Hyaluronic acid gel
DEVICERestylane Lyft Lidocaine
Hyaluronic acid gel
Sponsors
Galderma R&D
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045 | 12 weeks | Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment |
Countries
Sweden
Outcome results
None listed