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

Galderma R&D12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Safety

Interventions

GP0045DEVICE

Hyaluronic acid gel

Restylane Lyft LidocaineDEVICE

Hyaluronic acid gel

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CTC

Uppsala, Sweden

Outcomes

Primary Outcomes

The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045

Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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