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To evaluate 10 days of pretreatment with a serum (Test Product/Marvel AM) to the lower back, followed by a single exposure of 90J/cm2 HEV (High Energy Visible) light {400-450nm wavelengths} in healthy male or female volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fitzpatrick Skin Types I-III | Experimental | Volunteers will return to the clinic after Baseline for 10 additional, consecutive days for study staff to apply approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back. Volunteers will have digital images of the three (3) areas on the lower back that comprise the entire test region taken at Baseline, and 24hrs post 90J/cm2 HEV light exposure. |
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| Fitzpatrick Skin Types IV-V | Experimental | Volunteers will return to the clinic after Baseline for 10 additional, consecutive days for study staff to apply approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back. Volunteers will have digital images of the three (3) areas on the lower back that comprise the entire test region taken at Baseline, and 24hrs post 90J/cm2 HEV light exposure. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marvel AM | Other | Study staff will perform each application of approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back at each of ten sequential visits. |
| Measure | Description | Time Frame |
|---|---|---|
| Photographs for detection of changes in the treatment areas. | Photographic images of the lower back, will be captured utilizing a digital system. Photos may be taken from multiple angles to allow for easy detection of changes in the treatment areas. | Baseline, Day 11 |
| Chromamemter instrument will be used to assess the change of color on the skin. | Chromameter instrument will be used to measure color on the skin. | Baseline, Day 11 |
| Punch biopsies will be taken from the 3 different areas on the lower back to evaluate histological changes. | Punch biopsies will be taken from the 3 different areas on the lower back for histological evaluation. | Baseline, Day 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Makino | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McDaniel Institute of Anti Aging Research | Virginia Beach | Virginia | 23462 | United States |
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