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

A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

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 Overview

• Status: Completed
• Conditions: Safety
• Intervention / Treatment: Device: GP0045; Device: Restylane Lyft Lidocaine

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • CTC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: All subjects; Treatment with both GP0045 and Restylane Lyft Lidocaine	Device: GP0045; Hyaluronic acid gel; Device: Restylane Lyft Lidocaine; Hyaluronic acid gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 weeks

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2017
• Primary Completion (Actual): July 13, 2017
• Study Completion (Actual): July 13, 2017

Study Registration Dates

• First Submitted: April 18, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Hyaluronic Acid, Lidocaine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 43FE1629

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No