A Study to Evaluate the Safety Following Injection of GP0... | NCT03133325

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

NCT03133325

Sponsor

Galderma R&D

Status

Completed

Last Update Posted

Aug 25, 2022Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Safety

Interventions

GP0045
Restylane Lyft Lidocaine

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 19, 2017Actual

Primary Completion Date

Jul 13, 2017Actual

Completion Date

Jul 13, 2017Actual

First Submitted Date

Apr 18, 2017

First Submission Date that Met QC Criteria

Apr 25, 2017

First Posted Date

Apr 28, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2022

Last Update Posted Date

Aug 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
All subjects	Other	Treatment with both GP0045 and Restylane Lyft Lidocaine	Device: GP0045 Device: Restylane Lyft Lidocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GP0045	Device	Hyaluronic acid gel	All subjects
Restylane Lyft Lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary objective of the study is to evaluate the incidence, intensity, duration and onset of adverse events following injection of GP0045	Incidence, intensity, duration, and onset of adverse events collected and assessed by the Investigator 12 weeks post treatment	12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided