GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Galderma R&D270 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

270

Conditions

Cheek Augmentation

Interventions

GAL1704DEVICE

new dermal filler

Juvederm VolumaDEVICE

hyaluronic acid

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (15)

Galderma Study site

Los Angeles, California, United States

Galderma Study Site

Sacramento, California, United States

Galderma Study Site

Solana Beach, California, United States

Outcomes

Primary Outcomes

Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)

Change in midface fullness from Baseline to 12 weeks using the Medicis Midface Volume Score (MMVS), where a decreasing score correlates with increasing midface fullness, namely a score of 1 being the most full and a score of 4 being the least full.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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