Skip to main content
OpenTrials
Completed

NCT Number: NCT03300466

A Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

This is a study to assess the performance and safety of GP0045 when injected in the nasolabial folds.

There is an 18 months follow up period.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nasolabial Fold Safety

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Q-Med

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
  • Subjects with intent to undergo correction of both nasolabial folds

Exclusion criteria

  • Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (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 with an investigational product within 30 days before treatment

Treatment and study plan

GP0045

Device

Hyaluronic acid gel

COMPARATOR

Device

Hyaluronic acid gel

Primary outcomes

  1. Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale

    Time frame: 6 months

    The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.

Secondary outcomes

  1. Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale

    Time frame: 2 weeks, 3, 9, 12, 15 and 18 months

    The scale is a 5-graded NLF wrinkle severity scale ranging from absent (Grade 1) to severe (Grade 5). The response rate was defined as the percentage of subjects with at least 1 grade improvement in NLF wrinkle severity. Assessment made by blinded evaluator.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Controlled, Evaluator-blinded, Split Face Study to Evaluate the Performance and Safety of GP0045 for Correction of Moderate to Severe Nasolabial Folds

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 3, 2017
Registry last updated
Aug 26, 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.