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Main study: Randomized, evaluator-blinded, no treatment controlled multicenter study to evaluate safety and effectiveness of GAL1906 for the correction of wrinkles in the décolletage area.
Sub-study: To evaluate imaging interpretation of mammograms in subjects who were enrolled and treated in the 43USRV1906 main study. The sub-study will determine if hyaluronic acid injections in the décolletage interfere with diagnosis or interpretation of mammogram results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GAL1906 | Experimental | Experimental product for correction of wrinkles |
|
| Control | No Intervention | No treatment control | |
| Sub-Study | No Intervention | FDA requested extension for mammographic information, which was collected retrospectively as performed per standard of care (not performed as a study intervention) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GAL1906 | Device | hyaluronic acid dermal filler gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| Main study: The percentage of responders on the Galderma Décolletage Scale, as assessed live by the Blinded Evaluator, at Week 12. | Responder defined as at least one grade improvement from baseline | 12 weeks after initial injection |
| Sub-study: Incidence of Breast Image Interference, as Determined by Adjudicated Radiologist | Incidence of breast image interference, as determined by adjudicated radiologist, leading to potential misdiagnosis due to interference of GAL1906, by evaluation of all performed and collected diagnostic methods as well as comparison of post-treatment mammograms to pretreatment mammograms per subject if applicable. | Through the study completion, within 3 months of study start (approximately) |
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Inclusion Criteria for Main study:
Inclusion Criteria for Sub-study:
Exclusion Criteria for Main study:
Exclusion Criteria for Sub-study:
• Subject is pregnant or nursing AND has no mammogram taken post GAL1906 treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma Research Site | Birmingham | Alabama | 35209 | United States | ||
| Galderma Research Site |
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| Scottsdale |
| Arizona |
| 85255 |
| United States |
| Galderma Research Site | Redondo Beach | California | 90277 | United States |
| Galderma Research Site | San Diego | California | 92121 | United States |
| Galderma Research Site | Vista | California | 92083 | United States |
| Galderma Research Site | Westport | Connecticut | 06880 | United States |
| Galderma Research Site | Boynton Beach | Florida | 33472 | United States |
| Galderma Research Site | Coral Gables | Florida | 33146 | United States |
| Galderma Research Site | Alpharetta | Georgia | 30022 | United States |
| Galderma Research Site | Chicago | Illinois | 60654 | United States |
| Galderma Research Site | Baltimore | Maryland | 21208 | United States |
| Galderma Research Site | New York | New York | 10021 | United States |
| Galderma Research Site | Spring | Texas | 77388 | United States |
| Galderma Research Site | Mequon | Wisconsin | 53092 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | 14 | ||
| Jul 9, 2026 | Jul 9, 2026 | 15 |