Clinical trial NCT01846039: JUVÉDERM VOLUMA® to Enhance the Appearance of the Asian Nose
Official title: A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asian Nose Enhancement
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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
timeFrame: Baseline, Day 113
measure: Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient at Day 113
timeFrame: Baseline, Day 113
Secondary outcomes:
measure: Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician
timeFrame: Baseline, Days 239 and 421
measure: Percentage of Participants With a ≥ 1 Grade Improvement on the AAIS as Assessed by the Patient
timeFrame: Baseline, Days 239 and 421
measure: Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS)
timeFrame: Days 113, 239 and 421
measure: Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS)
timeFrame: Days 113, 239 and 421
measure: Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others
timeFrame: Days 113, 239 and 421
Other outcomes:
Locations:
city: Sydney
country: Australia
state: New South Wales
city: Gold Coast
country: Australia
state: Queensland
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.