A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

Galderma

Status: Completed

Conditions: Safety; Nasolabial Fold

Treatments: Device: GP0045; Device: Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT03300466

43FE1630

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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
• Subjects with intent to undergo correction of both nasolabial folds

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

GP0045

Experimental group

Description:

Treatment with GP0045

Treatment:

Device: GP0045

Comparator

Active Comparator group

Description:

Treatment with active comparator

Treatment:

Device: Comparator