N/A
N=270
GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Cheek Augmentation
Bottom Line
View on ClinicalTrials.gov: NCT03700047 ↗Enrolled (actual)
270
Serious AEs
1.1%
Results posted
May 2022
Primary outcome: Primary: Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) — -1.4; -0.1; -1.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GAL1704 (Device); Juvederm Voluma (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Galderma R&D
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS) |
-1.4; -0.1; -1.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03700047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.