NCT03133325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 18, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

April 19, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
Last Updated

August 25, 2022

Status Verified

August 1, 2017

Enrollment Period

3 months

First QC Date

April 18, 2017

Last Update Submit

August 24, 2022

Conditions

Safety

Keywords

Hyaluronic Acid, Lidocaine

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

All subjects

OTHER

Treatment with both GP0045 and Restylane Lyft Lidocaine

Device: GP0045Device: Restylane Lyft Lidocaine

Interventions

GP0045DEVICE

Hyaluronic acid gel

All subjects
Restylane Lyft LidocaineDEVICE

Hyaluronic acid gel

All subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Participation in any other clinical study within 30 days before treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTC

Uppsala, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2017

First Posted

April 28, 2017

Study Start

April 19, 2017

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

August 25, 2022

Record last verified: 2017-08

Locations

SE(1)