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

Safety Clinical Trial

Official title:

A Randomized, Split Arm Study to Evaluate the Safety Following Injection of GP0045 Compared to Restylane Lyft Lidocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133325
• Other study ID #: 43FE1629
• Status: Completed
• Phase: N/A
• Start date: April 19, 2017
• Est. completion date: July 13, 2017

Study information

• Verified date: August 2017
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 13, 2017
• Est. primary completion date: July 13, 2017
• 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

• 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

Related Conditions & MeSH terms

• Safety

Intervention

Device:
• GP0045
Hyaluronic acid gel
• Restylane Lyft Lidocaine
Hyaluronic acid gel

Locations

Country	Name	City	State
Sweden	CTC	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	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