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

Safety Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03300466
• Other study ID #: 43FE1630
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: April 24, 2019

Study information

• Verified date: April 2020
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 24, 2019
• Est. primary completion date: April 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasolabial Fold
• Safety

Intervention

Device:
• GP0045
Hyaluronic acid gel
• Comparator
Hyaluronic acid gel

Locations

Country	Name	City	State
Sweden	Q-Med	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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