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To assess the safety and efficacy of an ablative fractional, 2940-nm laser combined with the US Impact and cosmetic -formulations for improving the appearance of wrinkles, acne scars and pigmented skin.
This is a randomized, split face & dorsal hand side by side study. The purpose of the side by side study is to determine whether the use of the Impact with the ablative fractional 2940nm laser and cosmetics improves the cosmetic outcomes when compared to using just the ablative fractional 2940nm laser with the cosmetics.
This is a non-significant risk aesthetic clinical study. Only cosmetic formulations will be used during the study, These cosmetic formulations do not contain any ingredient categorized as a drug by the FDA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erbium plus cosmetics plus Impact | Active Comparator | Erbium 2940 plus cosmetics plus Impact Patient shall be treated with erbium 2940nm laser, cosmetics and the Impact. |
|
| Erbium 2940 plus cosmetics | Active Comparator | Erbium 2940 plus cosmetics Patient shall be treated with erbium 2940nm laser, cosmetics |
|
| Erbium 2940 plus cosmetics plus Impact | Active Comparator | Patient shall be treated with erbium 2940nm laser, cosmetics and the Impact. |
|
| Erbium 2940nm plus cosmetics | Active Comparator | Patients shall be treated with Erbium 2940nm laser plus cosmetics only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erbium 2940 plus cosmetics plus Impact | Device | Laser used in all arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Photographs to determine improvement of appearance | An independent panel of qualified blinded physicians (masked) with respect to subject-identity, photo chronology, treatment methodology (with/without Impact module), study time point, and treatment assignment will grade the photographs as determined by:
| 4 months |
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Inclusion Criteria:
Facial wrinkling, acne scars or pigmentation.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from participation:
The following are exclusion criteria for subjects in this study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NY Derm LLC | New York | New York | 10028 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 14, 2018 | |
| Reset | Feb 7, 2018 | |
| Release | Aug 17, 2020 | |
| Reset | Aug 31, 2020 | |
| Release | Mar 18, 2023 | |
| Reset | Apr 12, 2023 | |
| Release | Aug 16, 2023 | |
| Reset | Sep 8, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 14, 2018 | Feb 7, 2018 | |||
| Aug 17, 2020 |
| ID | Term |
|---|---|
| D007834 | Lasers |
| ID | Term |
|---|---|
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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| Erbium 2940 plus cosmetics | Device | laser |
|
|
| Aug 31, 2020 |
| Mar 18, 2023 | Apr 12, 2023 |
| Aug 16, 2023 | Sep 8, 2023 |