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Safety and Effectiveness of JUVÉDERM® VOLUMA® With Lidocaine for Improvement of Volume and Aesthetic Appearance of the Nose in Chinese Adults

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Allergan

Status

Completed

Conditions

Nose Enhancement

Treatments

Device: JUVÉDERM® VOLUMA® with Lidocaine
Other: No-treatment control

Study type

Interventional

Funder types

Industry

Identifiers

NCT03430986
1894-701-008

Details and patient eligibility

About

The purpose of this study is to determine whether VOLUMA with Lidocaine is safe and effective for the improvement of volume and aesthetic appearance of the nose in the Chinese population.

Enrollment

164 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Is not satisfied with his/her aesthetic appearance due to structural features of his/her nose and assessed as either "dissatisfied" or "very dissatisfied" by using the 5-point Nose Satisfaction Scale (NSS)
  • Requires a total volume of at least 0.5 mL but not exceeding 3.0 mL of VOLUMA with Lidocaine for initial and touch-up treatment combined, and treatment to the nasal dorsum is mandatory to achieve an aesthetic improvement in the subject's nose appearance, in the Treating Investigator (TI's) opinion
  • Has a reasonable treatment goal for aesthetic improvement in nose, in the TI's opinion. Participant and TI have aligned the treatment goals.

Exclusion criteria

  • Has a small, shallow nose such that the volume of filler implant needed to create the desired dorsal height is in excess of the ability of the skin and soft tissue to expand and accommodate the implant
  • Has active autoimmune disease
  • Is on a concurrent regimen of lidocaine or structurally-related local anesthetics (eg, bupivacaine)
  • Is on an ongoing regimen of anti-coagulation therapy (eg, warfarin)
  • Within 10 days of undergoing study device injection, is on an ongoing regimen of medications (eg, aspirin or ibuprofen) or other substances (eg, high doses of Vitamin C or Vitamin E or herbal supplements with garlic, gingko biloba, or ginseng) known to increase coagulation time, or is currently menstruating (study treatment may be delayed as necessary to accommodate menstrual period cessation and/or anticoagulation washout interval)
  • Has participated in any clinical trials within 4 weeks prior to signing the informed consent form (ICF) or is planning to participate in another clinical trial during the course of this study
  • Females who are pregnant, nursing, or planning a pregnancy during the course of the study. Females of childbearing potential who have a positive pregnancy test result during screening. Females who intend to breastfeed during the study. Females of childbearing potential who are unwilling to use birth control measures during the full course of the study. Birth control measures include oral contraceptives (stable) use for 2 or more cycles prior to screening), intrauterine devices, hormonal injections, hormonal implants, bilateral tube ligation, vasectomy, condom or diaphragm plus either contraceptive sponge, foam, or jelly

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

164 participants in 2 patient groups

JUVÉDERM® VOLUMA® with Lidocaine
Experimental group
Description:
Participants were treated with JUVÉDERM® VOLUMA® with Lidocaine injectable gel during the 24-week Control Period. Participants were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable. Follow-up continued in the 24-week Post-Control period.
Treatment:
Device: JUVÉDERM® VOLUMA® with Lidocaine
No-treatment Control
Experimental group
Description:
Participants received no treatment during the 24-week Control Period. After 24 weeks, participants had the option of treatment with JUVÉDERM® VOLUMA® with Lidocaine Injectable Gel in the nose area during the 24-week Post-Control period and were eligible for touch-up treatment 8 weeks after the initial treatment, if applicable.
Treatment:
Other: No-treatment control
Device: JUVÉDERM® VOLUMA® with Lidocaine

Trial documents
2

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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