GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Not Applicable

Completed

• Conditions: Cheek Augmentation
• Interventions: Device: GAL1704; Device: Juvederm Voluma

• Registration Number: NCT03700047
• Lead Sponsor: Galderma R&D

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-04
• Study First Submitted QC: 2018-10-05
• Study First Posted: 2018-10-09
• Study Start: 2018-10-18
• Primary Completion: 2019-06-10
• Study Completion: 2020-05-22
• Disposition First Submitted: 2020-09-15
• Results First Submitted: 2021-07-22
• Status Verified: 2022-05
• Results First Submitted QC: 2022-05-05
• Disposition First Submitted QC: 2022-05-05
• Results First Posted: 2022-05-31
• Disposition First Posted: 2022-05-31
• Last Update Submitted: 2022-08-24
• Last Update Posted: 2022-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GAL1704 (needle)	GAL1704	Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies.
GAL1704 (cannula/needle)	GAL1704	GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle.
Juvederm Voluma	Juvederm Voluma	Subjects randomized to control.

Primary Outcome Measures

Name	Time	Method
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)	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.

Trial Locations

Locations (3)

Galderma study site; 🇺🇸 Bellaire, Texas, United States

Galderma Study site; 🇺🇸 Dallas, Texas, United States

Galderma Study Site; 🇺🇸 Salt Lake City, Utah, United States