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

Not Applicable

Completed

• Conditions: Safety
• Interventions: Device: GP0045; Device: Restylane Lyft Lidocaine

• Registration Number: NCT03133325
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-18
• Study Start: 2017-04-19
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Primary Completion: 2017-07-13
• Study Completion: 2017-07-13
• Status Verified: 2017-08
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All subjects	GP0045	Treatment with both GP0045 and Restylane Lyft Lidocaine
All subjects	Restylane Lyft Lidocaine	Treatment with both GP0045 and Restylane Lyft Lidocaine

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045	12 weeks	Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment

Trial Locations

Locations (1)

CTC; 🇸🇪 Uppsala, Sweden