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Dermal Filler

GP0112 for Midface Contour Deficiency

N/A
Waitlist Available
Research Sponsored by Q-Med AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MMVS grade of 2, 3 or 4 on each side of the face as assessed by the Blinded Evaluator with limited difference between the two sides
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3, 6, 9, 12, 15,18 and 19 months
Awards & highlights

Study Summary

This trial is testing a new treatment for cheek augmentation and improving midface contour. It is comparing the new treatment to a current standard of care, and assessing safety and effectiveness.

Who is the study for?
Adults over 18 with mild to substantial cheek wrinkles or midface contour deficiencies, not pregnant or breastfeeding, willing to use birth control if of childbearing potential. Participants must not have had certain facial treatments within specified time frames and agree to avoid other facial procedures during the study.Check my eligibility
What is being tested?
The trial is testing GP0112 against Restylane Lyft Lidocaine for cheek augmentation and midface contour correction. It's a randomized study where participants are blindly assigned to receive either the test product or comparator in parallel groups at multiple centers.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as redness, swelling, pain, bruising; allergic reactions; lumps/bumps; itching; discoloration; rare risk of infection. Side effects can vary based on individual responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My facial skin condition is moderately to severely affected.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3, 6, 9, 12, 15,18 and 19 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3, 6, 9, 12, 15,18 and 19 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cheek structure
Secondary outcome measures
Effectiveness of GP0112 and comparator-control based on the validated 4-grade Medicis Midface Volume Scale (MMVS) assessment
Effectiveness of GP0112 and comparator-control in returning to social engagement
Effectiveness of GP0112 and comparator-control using Subject Satisfaction Questionnaire (SSQ)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: GP0112Experimental Treatment1 Intervention
GP0112 Single injection and optional touch up injection and re-treatment with GP0112
Group II: Restylane Lyft LidocaineActive Control1 Intervention
Restylane Lyft Lidocaine Single injection and optional touch up injection and re-treatment with Restylane Lyft Lidocaine
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GP0112
2022
N/A
~220

Find a Location

Who is running the clinical trial?

Q-Med ABLead Sponsor
80 Previous Clinical Trials
12,454 Total Patients Enrolled
Galderma R&DLead Sponsor
298 Previous Clinical Trials
60,107 Total Patients Enrolled
Study DirectorStudy DirectorGalderma R&D
1,207 Previous Clinical Trials
489,469 Total Patients Enrolled

Media Library

GP0112 (Dermal Filler) Clinical Trial Eligibility Overview. Trial Name: NCT05262777 — N/A
Midface Contour Deficiency Research Study Groups: Restylane Lyft Lidocaine, GP0112
Midface Contour Deficiency Clinical Trial 2023: GP0112 Highlights & Side Effects. Trial Name: NCT05262777 — N/A
GP0112 (Dermal Filler) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05262777 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are involved in the administration of this research?

"10 medical centres are currently participating in this trial, which may be found in cities such as Woodbridge, Winnipeg and Edmonton to name a few. In order to reduce the necessity of long distance travel, it is beneficial for patients to choose the location nearest them when enrolling."

Answered by AI

Is this analysis accessible to participants at the present time?

"Per the information posted on clinicaltrials.gov, this study is currently not seeking new patients; however, there are other trials that commenced recruitment after it was first listed (May 2nd 2022). The last update to its details was made in September 8th 2022."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Galderma Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
2022. "Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05262777.
~72 spots leftby Apr 2025
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