Evaluation of Efficacy and Safety of Hyaluronic Acid (HA) Product for Cheek Augmentation

Galderma

Status: Terminated

Conditions: Facial Tissue Augmentation

Treatments: Device: HA experimental; Device: HA comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02396251

43VZ1407

Details and patient eligibility

About

A multi-centre, evaluator-blinded study in subjects undergoing cheek augmentation. The study is designed to assess efficacy with regard to aesthetic midface augmentation and safety after treatment with HA product.

Enrollment: 48 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide a signed and dated informed consent to participate in the study including release of copyright of images
• Man or woman aged 18 years or older
• Be willing to abstain from any other facial plastic surgical or cosmetic procedures in close proximity to the treated area

Exclusion criteria

• Known/previous allergy or hypersensitivity to any injectable HA gel
• History of bleeding disorder or treatment with anticoagulants, thrombolytics, or inhibitors of platelet aggregation, omega-3, or vitamin E within 2 weeks before treatment
• Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy, topical retinoids, systemic or topical corticosteroids within 3 months before treatment and systemic retinoids within 6 months before treatment
• Previous tissue augmenting therapy or contouring with permanent filler, fat-injection or permanent implant placed in the area to be treated
• The subject is, in the opinion of the investigator, unlikely to comply with the clinical investigational plan or is unsuitable for any other reason

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 2 patient groups

HA experimental

Experimental group

Description:

HA experimental only

Treatment:

Device: HA experimental

HA comparator

Active Comparator group

Description:

HA experimental + HA comparator

Treatment:

Device: HA comparator

Device: HA experimental