Skip to main content
OpenTrials
Completed

NCT Number: NCT03133325

A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTC

Uppsala, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GP0045

Device

Hyaluronic acid gel

Restylane Lyft Lidocaine

Device

Hyaluronic acid gel

Primary outcomes

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

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 28, 2017
Registry last updated
Aug 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.