N/A N=20 Randomized Single-blind Treatment

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

Nasolabial Fold · Safety

Bottom Line

View on ClinicalTrials.gov: NCT03300466 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Apr 2020

Primary outcome: Primary: Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale — 63.2; 68.4 percentage of participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: GP0045 (Device); Comparator (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Galderma R&D
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	100; 100; 89.5; 89.5; 36.8; 26.3	—
SECONDARY Response Rate in Treatment of Nasolabial Fold (NLF) Based on a Scale	100; 100; 89.5; 89.5; 36.8; 26.3	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03300466). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.