JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT01846039
Collaborator
(none)
29
2
1
16.1
14.5
0.9

Study Details

Study Description

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
  • Device: Crosslinked hyaluronic acid gel
N/A

Study Design

Study Type:
Interventional
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 :
Apr 1, 2013
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Aug 5, 2014

Arms and Interventions

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 Names:
  • JUVÉDERM VOLUMA®
  • Outcome Measures

    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 [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 [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 [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 [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) [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) [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 [Days 113, 239 and 421]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Sydney New South Wales Australia
    2 Gold Coast Queensland Australia

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01846039
    Other Study ID Numbers:
    • VOLXC-AP-ND-001
    First Posted:
    May 3, 2013
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Period Title: Overall Study
    STARTED 29
    COMPLETED 27
    NOT COMPLETED 2

    Baseline Characteristics

    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Overall Participants 29
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    40.2
    (11.78)
    Sex: Female, Male (Count of Participants)
    Female
    26
    89.7%
    Male
    3
    10.3%

    Outcome Measures

    1. Primary Outcome
    Title 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
    Description 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.
    Time Frame Baseline, Day 113

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Number [percentage of participants]
    93.1
    321%
    2. Primary Outcome
    Title Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
    Description 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.
    Time Frame Baseline, Day 113

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Number [percentage of participants]
    93.1
    321%
    3. Secondary Outcome
    Title Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician
    Description 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.
    Time Frame Baseline, Days 239 and 421

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Day 239
    100.0
    344.8%
    Day 421
    96.6
    333.1%
    4. Secondary Outcome
    Title Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient
    Description 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
    Time Frame Baseline, Days 239 and 421

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Day 239
    96.6
    333.1%
    Day 421
    96.6
    333.1%
    5. Secondary Outcome
    Title Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)
    Description 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.
    Time Frame Days 113, 239 and 421

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Day 113
    93.1
    321%
    Day 239
    89.7
    309.3%
    Day 421
    89.7
    309.3%
    6. Secondary Outcome
    Title Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)
    Description 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.
    Time Frame Days 113, 239 and 421

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Day 113
    82.8
    285.5%
    Day 239
    82.8
    285.5%
    Day 421
    79.3
    273.4%
    7. Secondary Outcome
    Title Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others
    Description
    Time Frame Days 113, 239 and 421

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat population included all enrolled participants who received treatment.
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    Measure Participants 29
    Day 113
    89.7
    309.3%
    Day 239
    89.7
    309.3%
    Day 421
    86.2
    297.2%

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title JUVÉDERM VOLUMA®
    Arm/Group Description Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
    All Cause Mortality
    JUVÉDERM VOLUMA®
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    JUVÉDERM VOLUMA®
    Affected / at Risk (%) # Events
    Total 0/29 (0%)
    Other (Not Including Serious) Adverse Events
    JUVÉDERM VOLUMA®
    Affected / at Risk (%) # Events
    Total 29/29 (100%)
    General disorders
    Injection site swelling 28/29 (96.6%)
    Injection site erythema 20/29 (69%)
    Injection site bruising 16/29 (55.2%)
    Injection site pain 11/29 (37.9%)
    Injection site discomfort 8/29 (27.6%)
    Injection site hypoaesthesia 2/29 (6.9%)
    Injection site reaction 2/29 (6.9%)
    Infections and infestations
    Nasopharyngitis 3/29 (10.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Therapeutic Area Head,
    Organization Allergan, Inc
    Phone 714-246-4500
    Email clinicaltrials@allergan.com
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT01846039
    Other Study ID Numbers:
    • VOLXC-AP-ND-001
    First Posted:
    May 3, 2013
    Last Update Posted:
    Apr 16, 2019
    Last Verified:
    Apr 1, 2019