What is the mechanism of action of this treatment?

Dermal fillers, such as hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid, are commonly used for treating Midface Contour Deficiency. Hyaluronic acid fillers provide immediate volume by attracting and retaining water, while calcium hydroxylapatite acts as a scaffold for collagen production, offering longer-lasting results. Poly-L-lactic acid stimulates collagen production over time, leading to gradual and sustained improvement. These mechanisms are important for patients to understand as they influence the onset of results, duration of effects, and potential side effects, helping to set realistic treatment expectations.

What side effects are associated with this type of intervention?

The most common side effects of dermal fillers for midface contour deficiency, such as hyaluronic acid (HA) fillers, include temporary redness, swelling, bruising, and pain at the injection site. Other potential side effects can include lumps or bumps under the skin, asymmetry, and in rare cases, infection or allergic reactions. These side effects are generally mild and resolve on their own within a few days to weeks.

What prior FDA approvals exist?

The FDA has approved several dermal fillers for the treatment of midface contour deficiencies, including products like Juvéderm and Restylane. These fillers, primarily composed of hyaluronic acid, are commonly used for cheek augmentation and correction of midface contour deficiencies. Other approved treatments include poly-L-lactic acid (Sculptra), which stimulates collagen production for longer-lasting results. These treatments have been shown to improve facial volume and contour, with varying durations of effect and safety profiles.

What other types of research exist?

Promising alternatives to GP0112 for midface contour deficiency include Uma Jeunesse®, which uses a new crosslinking technology with BDDE, and Juvéderm® Ultra 3, both of which have demonstrated effectiveness and safety in clinical studies. Additionally, Perlane (non-animal stabilized hyaluronic acid) has shown improvements in global aesthetic appearance and nasolabial fold reduction when used for midfacial volume augmentation.

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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

Must not have

Previous facial surgery near the treatment area that could interfere with study safety and/or effectiveness assessments

Presence of disease or lesions near or on the area to be treated

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3, 6, 9, 12, 15,18 and 19 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing GP0112, a treatment to improve cheek and midface appearance, on people who want fuller cheeks and better midface shape. It likely works by adding volume to these areas.

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.

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.

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

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My facial skin condition is moderately to severely affected.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I've had facial surgery near the area to be treated that might affect the study.

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I have cancer near or on the area that needs treatment.

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I am allergic to injectable hyaluronic acid or certain bacterial proteins.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3, 6, 9, 12, 15,18 and 19 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cheek structure

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dermal fillers, such as hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid, are commonly used for treating Midface Contour Deficiency. Hyaluronic acid fillers provide immediate volume by attracting and retaining water, while calcium hydroxylapatite acts as a scaffold for collagen production, offering longer-lasting results. Poly-L-lactic acid stimulates collagen production over time, leading to gradual and sustained improvement. These mechanisms are important for patients to understand as they influence the onset of results, duration of effects, and potential side effects, helping to set realistic treatment expectations.

Quantitative assessment of augmentation therapy.Chin Microgenia: A Clinical Comparative Study.