A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

Galderma

Status: Completed

Conditions: Safety

Treatments: Device: Restylane Lyft Lidocaine; Device: GP0045

Study type: Interventional

Funder types: Industry

Identifiers

NCT03133325

43FE1629

Details and patient eligibility

About

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.

Enrollment: 12 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
• 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

All subjects

Other group

Description:

Treatment with both GP0045 and Restylane Lyft Lidocaine

Treatment:

Device: Restylane Lyft Lidocaine

Device: GP0045