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Safety and Effectiveness of Juvéderm® VOLUMA XC Injectable Gel for Cheek Augmentation

2010-07-15 17:00:00 | BioPortfolio

Summary

Multicenter, single-blind, randomized, "no-treatment" control study to demonstrate the safety and effectiveness of VOLUMA XC for deep injection for cheek augmentation to correct age-related volume deficit in the mid-face.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Conditions

Mid-facial Volume Deficit Related to Aging

Intervention

Juvéderm® VOLUMA XC

Location

Los Angeles
California
United States

Status

Active, not recruiting

Source

Allergan Medical

Results (where available)

View Results

Links

Published on BioPortfolio: 2010-07-15T17:00:00-0400

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Expanding Treatment Options for Injectable Agents.

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Medical and Biotech [MESH] Definitions

The process of aging due to changes in the structure and elasticity of the skin over time. It may be a part of physiological aging or it may be due to the effects of ultraviolet radiation, usually through exposure to sunlight.

The volume of BLOOD passing through the HEART per unit of time. It is usually expressed as liters (volume) per minute so as not to be confused with STROKE VOLUME (volume per beat).

Severe or complete loss of facial muscle motor function. This condition may result from central or peripheral lesions. Damage to CNS motor pathways from the cerebral cortex to the facial nuclei in the pons leads to facial weakness that generally spares the forehead muscles. FACIAL NERVE DISEASES generally results in generalized hemifacial weakness. NEUROMUSCULAR JUNCTION DISEASES and MUSCULAR DISEASES may also cause facial paralysis or paresis.

Pain in the facial region including orofacial pain and craniofacial pain. Associated conditions include local inflammatory and neoplastic disorders and neuralgic syndromes involving the trigeminal, facial, and glossopharyngeal nerves. Conditions which feature recurrent or persistent facial pain as the primary manifestation of disease are referred to as FACIAL PAIN SYNDROMES.

The volume of air contained in the lungs at the end of a maximal inspiration. It is the equivalent to each of the following sums: VITAL CAPACITY plus RESIDUAL VOLUME; INSPIRATORY CAPACITY plus FUNCTIONAL RESIDUAL CAPACITY; TIDAL VOLUME plus INSPIRATORY RESERVE VOLUME plus functional residual capacity; or tidal volume plus inspiratory reserve volume plus EXPIRATORY RESERVE VOLUME plus residual volume.

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