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

A Randomized, Controlled, Evaluator-blinded, Split Face 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.

Study Overview

• Status: Completed
• Conditions: Safety; Nasolabial Fold
• Intervention / Treatment: Device: GP0045; Device: Comparator

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden
    • Q-Med

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: GP0045; Treatment with GP0045	Device: GP0045; Hyaluronic acid gel
ACTIVE_COMPARATOR: Comparator; Treatment with active comparator	Device: Comparator; Hyaluronic acid gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	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.	2 weeks, 3, 9, 12, 15 and 18 months

Collaborators and Investigators

• Sponsor: Galderma R&D

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2017
• Primary Completion (ACTUAL): April 27, 2018
• Study Completion (ACTUAL): April 24, 2019

Study Registration Dates

• First Submitted: September 28, 2017
• First Submitted That Met QC Criteria: September 28, 2017
• First Posted (ACTUAL): October 3, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Hyaluronic Acid, Lidocaine
• Other Study ID Numbers: 43FE1630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No