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The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths.
The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Facial skin treatment | Experimental | Facial skin treatment using the Alma Hybrid system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Facial skin treatment | Device | Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigator assessment | Investigator assessment of the overall facial skin aesthetic appearance using a 5 point Likert scale (when "1" indicate "not at all improved" and "5" indicates " very much improved" | 3 month after last treatment |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Griffin, MD | Dermatology Associates of Plymouth Meeting, P.C. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology Associates of Plymouth Meeting, P.C. | Plymouth Meeting | Pennsylvania | 19762 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 2, 2022 | Dec 1, 2022 | 4 | ||
| Dec 6, 2022 |
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| Dec 27, 2022 |
| 5 |
| Jan 8, 2023 | Jan 30, 2023 | 6 |
| Jan 31, 2023 | Feb 24, 2023 | 7 |
| Feb 28, 2023 | Mar 23, 2023 | 8 |
| Jul 23, 2023 | Aug 7, 2023 | 9 |
| Oct 21, 2023 | Nov 7, 2023 | 10 |