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The objective of this study is to examine the ability of dermal rejuvenation therapies to protect geriatric skin from ultraviolet light (UVB)-induced carcinogenesis. Skin cancers (including basal cell carcinoma and squamous cell carcinoma) are the most common types of malignancy and are related to UVB exposure in sunlight. UVB-irradiation of skin causes specific DNA damage to keratinocytes that can lead to cancer-causing mutations if they are allowed to persist in proliferating cells. Moreover, the incidence of skin cancers is much greater in elderly over younger individuals. The objective of the present study is to build upon our previous data and test the effect of a non ablative Nd:YAG laser (LaserGenesis) of a localized area of skin on dermal IGF-1 production and UVB-mediated keratinocyte effects. Treatment of skin using a non ablative high-peak power microsecond pulsed 1064 nm Nd:YAG laser (Cutera's LaserGenesisTM laser) leads to papillary dermal heating. The laser targets the microvasculature and stimulates collagen production while protecting the epidermis. Generally, Laser Genesis is used clinically to improve irregularities in the contour, texture, and color of the skin. Laser Genesis is also used to help treat photoaging by increasing collagen formation, suggesting that it stimulates fibroblast activity and thus possibly increases levels of protective IGF-1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UV Light | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UV Light (Laser Genesis) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers | Number of double positive cells per 1000 total basal layer keratinocytes | untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB |
| Measure | Description | Time Frame |
|---|---|---|
| Relative Level of IGF-1 mRNA in the Skin | IGF-1 mRNA per 100,000 beta-2 microglobulin mRNA. Beta-2 microglobulin mRNA was used as a reference gene for this assessment and that the data represent number of copies IGF-1/100,000 copies b2-microglobulin. | untreated and LaserGenesis treated, three months after treatment |
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Inclusion Criteria:
Exclusion Criteria:
Subjects will be asked the screening questions below as part of the inclusion/exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Department of Dermatology | Indianapolis | Indiana | 46202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | UV Light | UV Light (Laser Genesis). 1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | LaserGenesis Treatment | 1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms and a 5 mm spot size |
| 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, Categorical | Count of 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 | Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers | Number of double positive cells per 1000 total basal layer keratinocytes | untreated and laser treated biopsies were taken from each subject | Posted | Mean | Standard Deviation | positive cells/1000 basal layer cells | untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB |
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3 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 | LaserGenesis Treatment | 1064 nm laser at a fluence of 13-16 J/cm2 and a pulse width of 0.3 ms with a 5 mm spot size |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ally-Khan Somani | Indiana University School of Medicine | 317-944-7744 | somania@iupui.edu |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Relative Level of IGF-1 mRNA in the Skin | IGF-1 mRNA per 100,000 beta-2 microglobulin mRNA. Beta-2 microglobulin mRNA was used as a reference gene for this assessment and that the data represent number of copies IGF-1/100,000 copies b2-microglobulin. | untreated and laser treated biopsies were taken from each subject | Posted | Mean | Standard Error | relative mRNA | untreated and LaserGenesis treated, three months after treatment |
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| 0 |
| 11 |
| 0 |
| 11 |
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| 11 |
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