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

Not Applicable

Completed

• Conditions: Nasolabial Fold; Safety
• Interventions: Device: Comparator; Device: GP0045

• Registration Number: NCT03300466
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-28
• Study First Submitted QC: 2017-09-28
• Study Start: 2017-10-02
• Study First Posted: 2017-10-03
• Primary Completion: 2018-04-27
• Study Completion: 2019-04-24
• Results First Submitted: 2020-03-17
• Status Verified: 2020-04
• Results First Submitted QC: 2020-04-01
• Results First Posted: 2020-04-17
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator	Comparator	Treatment with active comparator
GP0045	GP0045	Treatment with GP0045

Primary Outcome Measures

Name	Time	Method
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	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 Outcome Measures

Name	Time	Method
Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	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.

Trial Locations

Locations (1)

Q-Med; 🇸🇪 Uppsala, Sweden