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

Facial Tissue Augmentation Clinical Trial

Official title:

A Multi-Centre, Evaluator-Blinded Study to Evaluate Efficacy and Safety of R Volumizer for Cheek Augmentation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02396251
• Other study ID #: 43VZ1407
• Status: Terminated
• Phase: N/A
• Start date: February 28, 2015
• Est. completion date: November 14, 2017

Study information

• Verified date: September 2019
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 48
• Est. completion date: November 14, 2017
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Facial Tissue Augmentation

Intervention

Device:
• HA experimental

• HA comparator

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Responders in Midface Fullness Using Photo Scale	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.	3 months
Secondary	Percentage of Responders in Midface Fullness Using Photo Scale	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.	15 months