Status:
COMPLETED
A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
Lead Sponsor:
Galderma R&D
Conditions:
Nasolabial Fold
Safety
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds. There is an 18 months follow up period.
Eligibility Criteria
Inclusion
- 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
- Subjects with intent to undergo correction of both nasolabial folds
Exclusion
- Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (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 with an investigational product within 30 days before treatment
Key Trial Info
Start Date :
October 2 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03300466
Start Date
October 2 2017
End Date
April 24 2019
Last Update
August 26 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Q-Med
Uppsala, Sweden