GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

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.

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Key information

Conditions

Cheek Augmentation

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Galderma Study site, Los Angeles, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GAL1704

Device

new dermal filler

Juvederm Voluma

Device

hyaluronic acid

Primary outcomes

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

Time frame: 12 weeks

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.

Sponsors and collaborators

Lead sponsor

Galderma R&D

Industry

Registry information

Official study title

A Randomized, Evaluator-Blinded, Parallel, Comparator-Controlled Study to Evaluate the Safety and Effectiveness of GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Oct 9, 2018
Registry last updated: Aug 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed