A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds
NCT ID: NCT03300466
Last Updated: 2022-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2017-10-02
2019-04-24
Brief Summary
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There is an 18 months follow up period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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GP0045
Treatment with GP0045
GP0045
Hyaluronic acid gel
Comparator
Treatment with active comparator
Comparator
Hyaluronic acid gel
Interventions
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GP0045
Hyaluronic acid gel
Comparator
Hyaluronic acid gel
Eligibility Criteria
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Inclusion Criteria
* Signed and dated informed consent to participate in the study, including photo consent
* Subjects with intent to undergo correction of both nasolabial folds
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Galderma R&D
INDUSTRY
Responsible Party
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Principal Investigators
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Q-Med AB
Role: STUDY_DIRECTOR
Galderma R&D
Locations
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Q-Med
Uppsala, , Sweden
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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43FE1630
Identifier Type: -
Identifier Source: org_study_id
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