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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAL1704 (needle) | Experimental | Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies. |
|
| GAL1704 (cannula/needle) | Experimental | GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle. |
|
| Juvederm Voluma | Active Comparator | Subjects randomized to control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAL1704 | Device | new dermal filler |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Study site | Los Angeles | California | 90069 | United States | ||
| Galderma Study Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | GAL1704 (Needle) | Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies |
| FG001 | GAL1704 (Cannula/Needle) | GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 28, 2018 | Jul 22, 2021 |
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| Juvederm Voluma |
| Device |
hyaluronic acid |
|
| Sacramento |
| California |
| 95816 |
| United States |
| Galderma Study Site | Solana Beach | California | 92075 | United States |
| Galderma Study Site | Miami | Florida | 11137 | United States |
| Galderma Study Site | West Palm Beach | Florida | 33401 | United States |
| Galderma Study Site | New Orleans | Louisiana | 70115 | United States |
| Galderma Study Site | Baltimore | Maryland | 21208 | United States |
| Galderma Study Site | Chestnut Hill | Massachusetts | 02467 | United States |
| Galderma Study Site | Mount Kisco | New York | 10549 | United States |
| Galderma Study Site | New York | New York | 10021 | United States |
| Galderma Study Site | New York | New York | 10028 | United States |
| Galderma study site | Charleston | South Carolina | 29414 | United States |
| Galderma study site | Bellaire | Texas | 77401 | United States |
| Galderma Study site | Dallas | Texas | 75254 | United States |
| Galderma Study Site | Salt Lake City | Utah | 84101 | United States |
| FG002 | Juvederm Voluma | Subjects randomized to control. |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GAL1704 (Needle) | Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies |
| BG001 | GAL1704 (Cannula) | GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle |
| BG002 | Juvederm Voluma | Subjects randomized to control. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Fitzpatrick Skin Type (FST) | FST is a standardized skin classification system with 6 skin phototypes, where FST I represents the lightest skin color and FST VI represents the darkest skin color. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Per protocol population | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
|
|
1 year, 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GAL1704 (Needle) | Subjects randomized (2:1) to GAL1704 or Control for cheek augmentation and the correction of midface contour deficiencies | 0 | 142 | 0 | 141 | 6 | 141 |
| EG001 | GAL1704 (Cannula/Needle) | GAL1704 treatment using a split face design - one cheek treated using cannula and the other cheek treated using needle | 0 | 60 | 1 | 60 | 0 | 60 |
| EG002 | Juvederm Voluma | Subjects randomized to control. | 0 | 68 | 2 | 68 | 13 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Implant site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Implant site oedema | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Implant site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | QMedAB | (817) 961-500 | aestheticclinicaltrials@galderma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2018 | Jul 22, 2021 | SAP_001.pdf |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| FST II |
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| FST III |
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| FST IV |
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| FST V |
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| FST VI |
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