JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

NCT01846039 | Completed Results DMC

• 1 other identifier: VOLXC-AP-ND-001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With a ≥ 1 Grade Improvement on the Assessment of Aesthetic Improvement Scale (AAIS) as Assessed by the Central Evaluating Physician at Day 113

  The independent central evaluating physician evaluated the improvement of the participant's nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.

  Baseline, Day 113

• Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113

  The participant evaluated the improvement of their nose as compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Day 113. The percentage of participants with a ≥ 1 Grade Improvement from Baseline is reported.

  Baseline, Day 113

Secondary Outcomes (5)

• Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician

  Baseline, Days 239 and 421

• Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient

  Baseline, Days 239 and 421

• Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)

  Days 113, 239 and 421

• Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)

  Days 113, 239 and 421

• Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others

  Days 113, 239 and 421

Study Arms (1)

JUVÉDERM VOLUMA®

EXPERIMENTAL

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

Device: Crosslinked hyaluronic acid gel

Interventions

Crosslinked hyaluronic acid gel DEVICE

Up to 3 mL administered by intradermal injection

Also known as: JUVÉDERM VOLUMA®

JUVÉDERM VOLUMA®

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Sydney, New South Wales, Australia

Location

Unknown Facility

Gold Coast, Queensland, Australia

Location

Related Publications (1)

• 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.

  PMID: 27301371 BACKGROUND

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2013
• First Posted: May 3, 2013
• Study Start: April 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: August 5, 2014
• Last Updated: April 16, 2019
• Results First Posted: October 9, 2015

Record last verified: 2019-04

Locations

AU (2)