GP0112 for Midface Contour Deficiency

No longer recruiting at 10 trial locations

Overseen By Galderma Clinical Project Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Q-Med AB

Must not be taking: Anticoagulants, NSAIDs, Corticosteroids, others

Disqualifiers: Allergies, Facial surgery, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 3 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called GP0112, a dermal filler, for improving cheek fullness and correcting midface contour issues. It compares GP0112 with an existing treatment, Restylane Lyft Lidocaine, to determine which is more effective and safer. Individuals with mild to substantial cheek volume loss who are open to trying a new facial treatment and have not had recent cosmetic procedures in that area may be suitable candidates. As an unphased trial, this study provides a unique opportunity to explore innovative treatments before they become widely available.

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications that can prolong bleeding times, like aspirin or other NSAIDs, Omega 3, or Vitamin E, within 14 days before the injection. Other medications, such as systemic corticosteroids and certain retinoids, also have specific restrictions before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that GP0112 has been tested for safety and effectiveness in cheek enhancement. These studies indicate that GP0112 is generally well-tolerated, with most individuals experiencing only mild side effects like redness or swelling at the injection site. Serious side effects are rare.

The other treatment in the trial, Restylane Lyft Lidocaine, already has FDA approval for cheek enhancement, indicating a known safety record, which can be reassuring.

Evidence so far suggests that both GP0112 and Restylane Lyft Lidocaine are safe for cheek enhancement, with a low risk of major side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for midface contour deficiency, which typically involve dermal fillers like Restylane Lyft Lidocaine, GP0112 brings something new to the table. Researchers are excited about GP0112 because it offers an innovative approach with a unique active ingredient, potentially leading to longer-lasting results with fewer injections. This experimental treatment could mean fewer trips to the clinic for touch-ups, making it a more convenient option for patients seeking facial volume restoration. Additionally, GP0112 might provide a more natural look, which is always a plus for those concerned about aesthetic outcomes.

What evidence suggests that this trial's treatments could be effective for midface contour deficiency?

Research has shown that GP0112, one of the treatments in this trial, is being tested for its ability to improve cheek fullness and shape in individuals with midface contour issues. Previous patients have achieved good results using hyaluronic acid fillers, such as GP0112, to increase cheek volume and correct contour problems. Studies indicate that these fillers are generally safe and effective for similar conditions. The treatment involves injecting GP0112 into the cheeks to add volume and enhance facial balance. Early results suggest it could be a promising option for those seeking to improve their midface appearance. Another treatment option in this trial is Restylane Lyft Lidocaine, used as an active comparator. ^{1 6 7 8 9}

Who Is on the Research Team?

Study Director

Principal Investigator

Galderma R&D

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am using effective birth control and my pregnancy test was negative.

I agree not to have facial cosmetic procedures below my eyes during the study.

Ability to understand verbal explanations and written subject information in local language and give consent to participate in the study

Exclusion Criteria

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

I have had cosmetic procedures or implants within certain time limits.

I have not taken certain medications recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single injection and optional touch-up injection and re-treatment with GP0112 or Restylane Lyft Lidocaine

3 months

1 visit (in-person) for injection, optional follow-up visits for touch-up

Follow-up

Participants are monitored for safety and effectiveness after treatment using various scales and questionnaires

19 months

Regular assessments at 3, 6, 9, 12, 15, 18, and 19 months

What Are the Treatments Tested in This Trial?

Interventions

• GP0112
• Restylane Lyft Lidocaine

Trial Overview 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.

How Is the Trial Designed?

Group I: GP0112 Experimental Treatment 1 Intervention

GP0112 Single injection and optional touch up injection and re-treatment with GP0112

Group II: Restylane Lyft Lidocaine Active Control 1 Intervention

Restylane Lyft Lidocaine Single injection and optional touch up injection and re-treatment with Restylane Lyft Lidocaine

Who Is Running the Clinical Trial?

Q-Med AB

Lead Sponsor

Trials

81

Recruited

12,700+

Doug Caro

Q-Med AB

Chief Executive Officer

Economics degree from Florida State University

Dr. Johan Färnstrand

Q-Med AB

Chief Medical Officer

MD from Uppsala University

Galderma R&D

Lead Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05262777

Study Details | NCT05262777 | Safety and Effectiveness of ... ... study to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour deficiencies. Official Title. A Randomized ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20550471

Safety and Effectiveness of GP0112 for Cheek ... The purpose of this study is to evaluate the safety and effectiveness of GP0112 for cheek augmentation and correction of midface contour ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12362359/

A prospective case series study with 12-month follow-up Effectiveness, safety, and versatility of hyaluronic acid dermal filler in patients with reduced midface volume, chin retrusion, and/or loss of ...

4. bertuccimedspa.com bertuccimedspa.com/research/study/cheek-study-2/

A randomized, evaluator-blinded, parallel group, ... Evaluating the safety and effectiveness of GP0112 dermal filler for cheek augmentation and correction of midface contour deficiencies.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7671260/

The Role of Clinical Examination in Midface Volume ... The use of a treatment algorithm may improve outcomes for patients seeking injectable treatments for midfacial volume loss and contour deficiencies.

6. ctv.veeva.com ctv.veeva.com/study/safety-and-effectiveness-of-gp0112-for-cheek-augmentation-and-correction-of-midface-contour-deficien

Safety and Effectiveness of GP0112 for Cheek Augmentation ... A randomized, evaluator-blinded, parallel group, comparator-controlled, multicenter study to evaluate the safety and effectiveness of GP0112 ...

7. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT05098457?keyword=%22Cheek%22

San Mateo Clinical Trial Safety and Effectiveness ... A prospective, randomized, evaluator-blinded, comparator-controlled, parallel group, multicenter study to evaluate the safety and effectiveness of GP0112 ...

8. cochranelibrary.com cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-02029579&doi=10.1002/central/CN-02029579&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Safety and Effectiveness of Juvéderm® VOLUMA XC ... A Study of the Safety and Effectiveness of JUVÉDERM VOLUMA® XC Injectable Gel for Cheek Augmentation Using Cannula · A Study to Assess Safety and Effectiveness ...

9. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf14/P140029S032B.pdf

SUMMARY OF SAFETY AND EFFECTIVENESS DATA (SSED) Restylane Contour is indicated for use in cheek augmentation and correction of midface contour deficiencies in patients over the age of 21. III.