GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies

NCT03700047 | Completed Results FDA Device

• 1 other identifier: 43USV1704
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 15

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.

Conditions

Cheek Augmentation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

GAL1704 (needle)

EXPERIMENTAL

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

Device: GAL1704

GAL1704 (cannula/needle)

EXPERIMENTAL

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

Device: GAL1704

Juvederm Voluma

ACTIVE COMPARATOR

Subjects randomized to control.

Device: Juvederm Voluma

Interventions

GAL1704 DEVICE

new dermal filler

GAL1704 (cannula/needle); GAL1704 (needle)

Juvederm Voluma DEVICE

hyaluronic acid

Juvederm Voluma

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Galderma R&D: lead

Study Sites (15)

Galderma Study site

Los Angeles, California, 90069, United States

Location

Galderma Study Site

Sacramento, California, 95816, United States

Location

Galderma Study Site

Solana Beach, California, 92075, United States

Location

Galderma Study Site

Miami, Florida, 11137, United States

Location

Galderma Study Site

West Palm Beach, Florida, 33401, United States

Location

Galderma Study Site

New Orleans, Louisiana, 70115, United States

Location

Galderma Study Site

Baltimore, Maryland, 21208, United States

Location

Galderma Study Site

Chestnut Hill, Massachusetts, 02467, United States

Location

Galderma Study Site

Mount Kisco, New York, 10549, United States

Location

Galderma Study Site

New York, New York, 10021, United States

Location

Galderma Study Site

New York, New York, 10028, United States

Location

Galderma study site

Charleston, South Carolina, 29414, United States

Location

Galderma study site

Bellaire, Texas, 77401, United States

Location

Galderma Study site

Dallas, Texas, 75254, United States

Location

Galderma Study Site

Salt Lake City, Utah, 84101, United States

Location

Results Point of Contact

• Title: Clinical Project Manager
• Organization: QMedAB

aestheticclinicaltrials@galderma.com

(817) 961-500

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: October 18, 2018
• Primary Completion: June 10, 2019
• Study Completion: May 22, 2020
• Last Updated: August 26, 2022
• Results First Posted: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)