GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Galderma

Status: Completed

Conditions: Cheek Augmentation

Treatments: Device: GAL1704; Device: Juvederm Voluma

Study type: Interventional

Funder types: Industry

Identifiers

NCT03700047

43USV1704

Details and patient eligibility

About

An interventional study to evaluate the safety and effectiveness of GAL1704 for cheek augmentation and the correction of midface volume deficiencies by demonstrating non-inferiority in change from baseline, relative to an active comparator.

Enrollment: 270 patients

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects assessed at baseline by the Blinded Evaluator as Grade 2, 3, or 4 on the MMVS on each side of the midface.

Exclusion criteria

• Previous use of any HA based or collagen based biodegradable tissue augmentation therapy within 12 months prior to the baseline visit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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270 participants in 3 patient groups

GAL1704 (needle)

Experimental group

Description:

Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies.

Treatment:

Device: GAL1704

GAL1704 (cannula/needle)

Experimental group

Description:

GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle.

Treatment:

Device: GAL1704

Juvederm Voluma

Active Comparator group

Description:

Subjects randomized to control.

Treatment:

Device: Juvederm Voluma