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NCT07909421
A Study to Evaluate the Safety and Effectiveness of GP0112 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Conditions: Cheek Wrinkles, Midface Contour Deficiencies
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 326
Sponsor: Galderma R&D
Location: Galderma Investigational Site #6347 Chengdu
Summary
This is 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.
Approximately 326 subjects will be randomized (1:1) to either treatment with GP0112 or Juvéderm Voluma XC(also known as Juvéderm Voluma with lidocaine).
Eligibility Criteria
Inclusion Criteria:
1. Males and non-pregnant, non-breastfeeding females of Chinese origin and aged 18 years or older.
2. Intent to undergo cheek augmentation or correction of midface contour deficiencies treatment.
Exclusion Criteria:
1. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel or to gram positive bacterial proteins.
2. Known/previous allergy or hypersensitivity to local anesthetics, e.g. lidocaine or other amide-type anesthetics or nerve blocking agents.
3. Previous or present severe or multiple allergies manifested by severe reactions, such as anaphylaxis or angioedema, or family history of these conditions.
4. Prior surgery in the treatment area that in the Treatment investigator's opinion could interfere with the study safety and/or effectiveness assessments.
5. Any previous aesthetic procedures or implants.
6. Presence of any disease or lesions near or in the area to be treated.
Source: ClinicalTrials.gov (NCT07909421). StuddyBuddy aggregates publicly available trial information.