JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

Allergan

Status

Completed

Conditions

Asian Nose Enhancement

Treatments

Device: Crosslinked hyaluronic acid gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01846039

VOLXC-AP-ND-001

Details and patient eligibility

About

A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.

Enrollment

29 patients

Sex

All

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Asian subjects aged 20 years of age or older with dissatisfaction of their aesthetic appearance due to structural features of their nose
Subjects who, in the opinion of the Investigator, can achieve a clinically meaningful aesthetic correction of their nose with VOLUMA® treatment

Exclusion criteria

-Subjects requiring filler treatment in or around the tip of the nose or between the eyebrows (glabellar region) to achieve a good aesthetic outcome
prior nasal surgery, including grafts, implants or filler injection to the nose area
Subjects with a history of sinusitis or rhinitis
Subjects unlikely to achieve a meaningful aesthetic result with the prescribed dosage regimen of the study product.
Subjects receiving botulinum toxin treatment for any indication within 3 months of the study or planning to receive botulinum toxin during the study
Subjects who have previously received aesthetic treatment in the forehead, glabellar, and/or nose area with any dermal filler
Subjects with a history of any significant adverse events caused by dermal fillers
Subjects with a history of allergic responses to lidocaine or fillers
Subjects who are pregnant or breastfeeding or wish to become pregnant during the study
Subjects of child-bearing age who are not prepared to practice an adequate form of contraception during the course of the study
Subjects with traumatic scars in the treatment area or a history of active inflammation, infection, cancerous lesion, or an unhealed wound in the treatment area
Subjects requiring dental or oral surgery, including dental implants, during the study period
Subjects with a history of bleeding disorders
Subjects who are smokers
Subjects using blood thinning products within 10 days of the screening visit
Subjects with a history of connective tissue disease (e.g., rheumatoid arthritis, lupus, scleroderma, etc) causing skin scarring
Subjects with a history of untreated epilepsy or other significant medical conditions
Subjects with a history of alcoholism or drug abuse of dependence
Subjects participating or likely to participate in another clinical trial within 30 days of screening or during the 1 year period of the study
Subjects with any other medical condition, which in the opinion of the Investigator, might compromise the subject's ability to tolerate the injection procedure or comply with requirements of the study