Safety and Efficacy of Juvederm® VOLUMA™ for Correction of Mid-face Volume Deficiency

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Allergan

Status

Completed

Conditions

Mid-face Volume Deficiency

Treatments

Device: Cross-linked hyaluronic acid gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT01029535
VOL-AP01

Details and patient eligibility

About

This is a prospective, open-label experience study to be conducted at 6 clinical sites in Australia, with the objective to collect efficacy and safety information for Juvederm® VOLUMA™ when used for volumising the mid-face and cheek area.

Enrollment

103 patients

Sex

All

Ages

30 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with mild to severe mid-face and cheek volume deficit due to age-related changes, who are likely to improve by at least 2 grades following treatment with the study compound, based on a study-specific scale, as assessed by the study physician

Exclusion criteria

  • Subjects who have a pre-existing medical condition or who have received any treatments or procedures which may impact on the assessment of the effects of the study compound.
  • Subjects with a history of allergies or other side effects to dermal fillers, lidocaine, hyaluronic acid or other component of the study compound.
  • Subjects were are pregnant or breast-feeding or who are of child-bearing potential and who are not prepared to practice an adequate form of contraception during the course of the study
  • Subjects with a history of alcoholism or drug abuse or dependence

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

103 participants in 1 patient group

Juvederm® VOLUMA™
Experimental group
Description:
Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
Treatment:
Device: Cross-linked hyaluronic acid gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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