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JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01846039
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : October 9, 2015
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asian Nose Enhancement Device: Crosslinked hyaluronic acid gel Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : September 1, 2013
Actual Study Completion Date : August 5, 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: JUVÉDERM VOLUMA®
Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
 Device: Crosslinked hyaluronic acid gel
Up to 3 mL administered by intradermal injection
Other Name: JUVÉDERM VOLUMA®


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline, 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.

  2. Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113 [ Time Frame: Baseline, 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.


Secondary Outcome Measures :
  1. Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician [ Time Frame: Baseline, Days 239 and 421 ]
    The independent central evaluating physician evaluated the improvement of the participant's nose compared to Baseline using the AAIS 5-point scale: -2 (much worse) to +2 (much improved) at Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported.

  2. Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient [ Time Frame: Baseline, Days 239 and 421 ]
    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 Days 239 and 421. The percentage of participants with a ≥ 1 grade improvement from Baseline is reported

  3. Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) [ Time Frame: Days 113, 239 and 421 ]
    Participants assessed their satisfaction with the appearance of their nose at Days 113, 239 and 421 using the NSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants who rated themselves as satisfied or very satisfied is reported.

  4. Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) [ Time Frame: Days 113, 239 and 421 ]
    Participants assessed their satisfaction with the study drug (VOLUMA) treatment at Days 113, 239 and 421 using the TSS 5-point scale: -2 (very dissatisfied) to 2 (very satisfied). The percentage of participants satisfied or very satisfied with study drug treatment is reported.

  5. Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others [ Time Frame: Days 113, 239 and 421 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01846039


Locations
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Australia, New South Wales
Sydney, New South Wales, Australia
Australia, Queensland
Gold Coast, Queensland, Australia
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Publications:

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01846039    
Other Study ID Numbers: VOLXC-AP-ND-001
First Posted: May 3, 2013    Key Record Dates
Results First Posted: October 9, 2015
Last Update Posted: April 16, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
 Physiological Effects of Drugs
Viscosupplements
Protective Agents