GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

Cheek Augmentation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700047
• Other study ID #: 43USV1704
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: May 22, 2020

Study information

• Verified date: May 2022
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: May 22, 2020
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cheek Augmentation

Intervention

Device:
• GAL1704
new dermal filler
• Juvederm Voluma
hyaluronic acid

Locations

Country	Name	City	State
United States	Galderma Study Site	Baltimore	Maryland
United States	Galderma study site	Bellaire	Texas
United States	Galderma study site	Charleston	South Carolina
United States	Galderma Study Site	Chestnut Hill	Massachusetts
United States	Galderma Study site	Dallas	Texas
United States	Galderma Study site	Los Angeles	California
United States	Galderma Study Site	Miami	Florida
United States	Galderma Study Site	Mount Kisco	New York
United States	Galderma Study Site	New Orleans	Louisiana
United States	Galderma Study Site	New York	New York
United States	Galderma Study Site	New York	New York
United States	Galderma Study Site	Sacramento	California
United States	Galderma Study Site	Salt Lake City	Utah
United States	Galderma Study Site	Solana Beach	California
United States	Galderma Study Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks