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

NCT ID: NCT02396251

Last Updated: 2022-08-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-11-14

Brief Summary

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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

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Conditions

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Facial Tissue Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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HA experimental

HA experimental only

Group Type EXPERIMENTAL

HA experimental

Intervention Type DEVICE

HA comparator

HA experimental + HA comparator

Group Type ACTIVE_COMPARATOR

HA experimental

Intervention Type DEVICE

HA comparator

Intervention Type DEVICE

Interventions

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HA experimental

Intervention Type DEVICE

HA comparator

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Galderma R&D

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Q-Med AB

Role: STUDY_DIRECTOR

Galderma R&D

Locations

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Gothenburg, , Sweden

Site Status

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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43VZ1407

Identifier Type: -

Identifier Source: org_study_id

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