JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

NCT ID: NCT01846039

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-01
• Study Completion Date: 2014-08-05

Brief Summary

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

Conditions

Asian Nose Enhancement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

JUVÉDERM VOLUMA®

Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.

Group Type: EXPERIMENTAL

Crosslinked hyaluronic acid gel

Intervention Type: DEVICE

Up to 3 mL administered by intradermal injection

Interventions

Crosslinked hyaluronic acid gel

Up to 3 mL administered by intradermal injection

Intervention Type: DEVICE

Other Intervention Names

JUVÉDERM VOLUMA®

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

Sydney, New South Wales, Australia

Gold Coast, Queensland, Australia

Countries

Australia

References

Liew S, Scamp T, de Maio M, Halstead M, Johnston N, Silberberg M, Rogers JD. Efficacy and Safety of a Hyaluronic Acid Filler to Correct Aesthetically Detracting or Deficient Features of the Asian Nose: A Prospective, Open-Label, Long-Term Study. Aesthet Surg J. 2016 Jul;36(7):760-72. doi: 10.1093/asj/sjw079. Epub 2016 Jun 14.

Reference Type: BACKGROUND

PMID: 27301371 (View on PubMed)

Other Identifiers

VOLXC-AP-ND-001

Identifier Type: -

Identifier Source: org_study_id