Asian Nose Enhancement Clinical Trial
Official title:
A Prospective, Open-label Study of the Safety and Efficacy of JUVÉDERM VOLUMA® to Enhance the Aesthetic Appearance of the Asian Nose
| Verified date | April 2019 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
A prospective, open-label, observational study of the safety and efficacy of JUVÉDERM VOLUMA® to enhance the aesthetic appearance of the Asian nose.
| Status | Completed |
| Enrollment | 29 |
| Est. completion date | August 5, 2014 |
| Est. primary completion date | September 1, 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
Australia,
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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Percentage of Participants With a = 1 Grade Improvement on the AAIS as Assessed by the Central Evaluating Physician | 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. | Baseline, Days 239 and 421 | |
| Secondary | Percentage of Participants With a = 1 Grade Improvement on the AAIS as Assessed by the Patient | 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 | Baseline, Days 239 and 421 | |
| Secondary | Percentage of Participants Satisfied or Very Satisfied Based on the Nose Satisfaction Scale (NSS) | 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. | Days 113, 239 and 421 | |
| Secondary | Percentage of Participants Satisfied or Very Satisfied Based on the Treatment Satisfaction Scale (TSS) | 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. | Days 113, 239 and 421 | |
| Secondary | Percentage of Participants Who Would Recommend VOLUMA Treatment of the Nose to Others | Days 113, 239 and 421 |