22 and older, any sex, with Cheek Augmentation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)Primary· 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.
Group
Value
95% CI
GAL1704 (Needle)
-1.4
-1.51 – -1.35
GAL1704 (Cannula/Needle)
-0.1
-0.16 – 0.05
Juvederm Voluma
-1.3
-1.44 – -1.20
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year, 2 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
GAL1704 (Needle)
Serious: 0/141 (0%)
Deaths: 0/142
GAL1704 (Cannula/Needle)
Serious: 1/60 (2%)
Deaths: 0/60
Juvederm Voluma
Serious: 2/68 (3%)
Deaths: 0/68
Serious adverse events (4 terms)
Reaction
System
GAL1704 (Needle)
GAL1704 (Cannula/Needle)
Juvederm Voluma
Pneumonia
Infections and infestations
—
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
—
Postoperative wound infection
Infections and infestations
—
—
—
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Galderma R&D
Last refreshed: 26 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03700047.