A Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2017-07-13

Brief Summary

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This is a study to assess the safety of GP0045 compared to Restylane Lyft Lidocaine.

There is a 12-week follow-up period. AEs will be recorded throughout the study.

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Detailed Description

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Conditions

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Safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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All subjects

Treatment with both GP0045 and Restylane Lyft Lidocaine

Group Type OTHER

GP0045

Intervention Type DEVICE

Hyaluronic acid gel

Restylane Lyft Lidocaine

Intervention Type DEVICE

Hyaluronic acid gel

Interventions

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GP0045

Hyaluronic acid gel

Intervention Type DEVICE

Restylane Lyft Lidocaine

Hyaluronic acid gel

Intervention Type DEVICE

Eligibility Criteria

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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
* Men or non-pregnant, non-breast feeding women aged 18 years or older

Exclusion Criteria

* Known/previous allergy or hypersensitivity to any injectable 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 within 30 days before treatment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes