Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Defic… (NCT05262777) | Clinical Trial Compass
CompletedNot Applicable
Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Canada211 participantsStarted 2022-05-02
Plain-language summary
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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability to adequately understand the verbal explanations and the written subject information provided in local language and ability and willingness to give consent to participate in the study. Signed and dated informed consent to participate in the study.
✓. Men and non-pregnant, non-breastfeeding women aged 18 years or older.
✓. MMVS grade of 2, 3 or 4 (mild to substantial loss of fullness in the midface area) on each side of the face as assessed by the Blinded Evaluator. The MMVS for each side of the face does not need to be equal, however the difference between the two sides should be limited to 1 grade.
✓. Subjects 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 (e.g., laser or chemical resurfacing, needling, facelift, lifting threads, radiofrequency etc.).
✓. Intent to undergo treatment for correction of midface volume deficit.
✓. If the subject is a female of childbearing potential, she agrees to use an acceptable form of effective birth control for the duration of the study and is willing to take a urine pregnancy test (UPT) at the screening/baseline visit, prior to treatment/injection, and at the end of study visit.
✓. Negative UPT for women of childbearing potential at the screening/baseline visit and all injection visits.
Exclusion criteria
✕. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
✕
What they're measuring
1
Demonstrate non-inferiority of GP0112 versus a comparator-control in cheek augmentation and correction of midface contour deficiencies
. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics or nerve blocking agents (if intended to be used for that subject).
✕. Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
✕. Previous facial surgery (e.g. facial fat removal, facelift and sinus surgery) in or near the treatment area that in the Treating Investigator´s opinion could interfere with the study safety and/or effectiveness assessments.
✕. Any previous aesthetic procedures or implants:
✕. History of cancer or previous radiation near or on the area to be treated.
✕. Presence of any disease or lesions near or on the area to be treated, e.g.,
✕. Evidence of scar-related disease or delayed healing activity within 1 year prior to the baseline visit, or subjects susceptible to keloid formation, hyperpigmentation or hypertrophic scarring.