Midface Volume Deficit
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Midface Volume Deficit
43N1CA2104 Enrolling

Midface Volume Deficit Research Trial (20 Months)


Age: 18 Years

Men and non-pregnant, non-breastfeeding women aged 18 years or older with the intent to undergo treatment (i.e. cheek augmentation) for correction of midface volume deficit, may qualify for this study. Individuals must have mild to substantial loss of fullness in the midface area, on each side of the face, and be willing to abstain from any other facial plastic surgical or cosmetic procedures below the level of the lower orbital rim for the duration of the study.

Participants will receive investigational product (active study treatment) or a comparative product, in the form of an injectable gel. Study treatment and study-related assessments will be provided at no cost. Reimbursement for study-related expenses may be provided.

Study participation could last about 20 months and involve about 12 visits to the study centre, plus 4 follow-up phone calls.


Official Title

A Randomized, Evaluator-blinded, Parallel Group, Comparator-controlled, Multicenter Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies

ClinicalTrials.gov ID

NCT05262777

Sponsor

Q-Med AB

Study Description

  • Brief Summary:

    Q-Med AB

  • Condition or Disease:

    Cheek Wrinkles,Midface Contour Deficiencies

  • Intervention/Treatment:

    Device: GP0112 Device: Restylane Lyft Lidocaine
  • Phase:

    Not Applicable

  • Ages Eligible for Study:

    18 Years and older (Adult,Older Adult)

  • Sexes Eligible for Study:

    All


Participating Locations


Participating Experts

Dr. Jaggi Rao

Dermatologist

Dr. G. Daniel Schachter, MD, FRCPC, DABD

Dermatologist

Dr. Sameh Hanna, MD, FAAD, DABD

Dermatologist

Dr. Maxwell Sauder

Dermatologist

Dr. Anatoli Freiman, MD, FRCPC, DABD

Dermatologist

Dr. Benjamin Barankin, MD, FRCPC

Dermatologist

Dr. Mani Raman, MD, FRCPC, DABD

Dermatologist

Dr. Marni Wiseman, MD, FRCPC

Dermatologist

Dr. Susan Poelman

Dermatologist

Dr. Andrei Metelitsa, MD, FRCPC

Dermatologist

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