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

Not Applicable

Terminated

• Conditions: Facial Tissue Augmentation
• Interventions: Device: HA experimental; Device: HA comparator

• Registration Number: NCT02396251
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-02-27
• Study Start: 2015-02-28
• Study First Submitted QC: 2015-03-17
• Study First Posted: 2015-03-24
• Primary Completion: 2016-12-19
• Study Completion: 2017-11-14
• Results First Submitted: 2019-06-12
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-30
• Results First Posted: 2019-10-01
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HA comparator	HA experimental	HA experimental + HA comparator
HA experimental	HA experimental	HA experimental only
HA comparator	HA comparator	HA experimental + HA comparator

Primary Outcome Measures

Name	Time	Method
Percentage of Responders in Midface Fullness Using Photo Scale	3 months	Evaluation of midface fullness, determined by the percentage of responders at 3 months after last treatment, in both cheeks, derived from the Blinded Evaluator's live assessment of a validated photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.

Secondary Outcome Measures

Name	Time	Method
Percentage of Responders in Midface Fullness Using Photo Scale	15 months	Evaluate midface fullness as determined by percentage of responders at 4 weeks and 6, 9, 12 and, if applicable, 15 months after last treatment as well as 4 weeks and 3 months after re-treatment, derived from the Blinded Evaluator's live assessment of photo scale. A responder was defined as a subject with ≥1 grade improvement from baseline in both cheeks.