GP0112 for Midface Contour Deficiency

Recruiting at 9 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

211 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Study Director

Principal Investigator

Galderma R&D

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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