Trial Outcomes & Findings for GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies (NCT NCT03700047)
NCT ID: NCT03700047
Last Updated: 2022-08-26
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
270 participants
Primary outcome timeframe
12 weeks
Results posted on
2022-08-26
Participant Flow
Participant milestones
| Measure |
GAL1704 (Needle)
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
|
GAL1704 (Cannula/Needle)
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
|
Juvederm Voluma
Subjects randomized to control.
|
|---|---|---|---|
|
Overall Study
STARTED
|
142
|
60
|
68
|
|
Overall Study
COMPLETED
|
126
|
50
|
58
|
|
Overall Study
NOT COMPLETED
|
16
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
GAL1704 for Cheek Augmentation and Correction of Midface Contour Deficiencies
Baseline characteristics by cohort
| Measure |
GAL1704 (Needle)
n=142 Participants
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
|
GAL1704 (Cannula)
n=60 Participants
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
|
Juvederm Voluma
n=68 Participants
Subjects randomized to control.
|
Total
n=270 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
52.7 years
n=99 Participants
|
52.1 years
n=107 Participants
|
54.7 years
n=206 Participants
|
52.7 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
129 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
58 Participants
n=206 Participants
|
242 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
125 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
226 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
142 participants
n=99 Participants
|
60 participants
n=107 Participants
|
68 participants
n=206 Participants
|
270 participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST I
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST II
|
40 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
72 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST III
|
65 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
120 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST IV
|
17 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST V
|
8 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Fitzpatrick Skin Type (FST)
FST VI
|
8 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
24 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Per protocol population
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.
Outcome measures
| Measure |
GAL1704 (Needle)
n=142 Participants
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
|
GAL1704 (Cannula/Needle)
n=58 Participants
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
|
Juvederm Voluma
n=68 Participants
Subjects randomized to control.
|
|---|---|---|---|
|
Assess Efficacy of Study Treatment Using Medicis Midface Volume Score (MMVS)
|
-1.4 score on a scale
Interval -1.51 to -1.35
|
-0.1 score on a scale
Interval -0.16 to 0.05
|
-1.3 score on a scale
Interval -1.44 to -1.2
|
Adverse Events
GAL1704 (Needle)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
GAL1704 (Cannula/Needle)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Juvederm Voluma
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GAL1704 (Needle)
n=141 participants at risk
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
|
GAL1704 (Cannula/Needle)
n=60 participants at risk
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
|
Juvederm Voluma
n=68 participants at risk
Subjects randomized to control.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/141 • 1 year, 2 months
|
0.00%
0/60 • 1 year, 2 months
|
1.5%
1/68 • Number of events 1 • 1 year, 2 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/141 • 1 year, 2 months
|
0.00%
0/60 • 1 year, 2 months
|
1.5%
1/68 • Number of events 1 • 1 year, 2 months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/141 • 1 year, 2 months
|
0.00%
0/60 • 1 year, 2 months
|
1.5%
1/68 • Number of events 1 • 1 year, 2 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/141 • 1 year, 2 months
|
1.7%
1/60 • Number of events 1 • 1 year, 2 months
|
0.00%
0/68 • 1 year, 2 months
|
Other adverse events
| Measure |
GAL1704 (Needle)
n=141 participants at risk
Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies
|
GAL1704 (Cannula/Needle)
n=60 participants at risk
GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle
|
Juvederm Voluma
n=68 participants at risk
Subjects randomized to control.
|
|---|---|---|---|
|
General disorders
Implant site pain
|
4.3%
6/141 • Number of events 16 • 1 year, 2 months
|
0.00%
0/60 • 1 year, 2 months
|
19.1%
13/68 • Number of events 49 • 1 year, 2 months
|
|
General disorders
Implant site oedema
|
2.1%
3/141 • Number of events 6 • 1 year, 2 months
|
0.00%
0/60 • 1 year, 2 months
|
10.3%
7/68 • Number of events 19 • 1 year, 2 months
|
|
General disorders
Implant site erythema
|
1.4%
2/141 • Number of events 6 • 1 year, 2 months
|
0.00%
0/60 • 1 year, 2 months
|
8.8%
6/68 • Number of events 12 • 1 year, 2 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PIs agree not to present or publish any data or reports collected individually or by subgroup of sites prior to full, initial publication based on all data obtained from all sites.
- Publication restrictions are in place
Restriction type: OTHER