Pre-cancerous Geriatric Skin
Conditions
Brief summary
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.
Interventions
DEVICEUV Light (Laser Genesis)
Sponsors
Indiana University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* Only subjects older than 65 years will be enrolled. * Subject's skin type must be Fair, Fitzpatrick type I or II.
Exclusion criteria
* Subjects who have underlying diseases that could affect wound healing (eg, diabetes mellitus) * on medications that are known photosensitizers, * or have a history of abnormal scarring (eg, keloids) will be excluded. Subjects will be asked the screening questions below as part of the inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers | untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB | Number of double positive cells per 1000 total basal layer keratinocytes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Relative Level of IGF-1 mRNA in the Skin | untreated and LaserGenesis treated, three months after treatment | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | LaserGenesis Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 11 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers
Number of double positive cells per 1000 total basal layer keratinocytes
Time frame: untreated and LaserGenesis treated, three months after treatment, 24 hours after 350 J/m2 of UVB
Population: untreated and laser treated biopsies were taken from each subject
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LaserGenesis Treatment | Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers | Untreated skin | 21.5 positive cells/1000 basal layer cells | Standard Deviation 16.3 |
| LaserGenesis Treatment | Difference in Basal Layer Keratinocytes Positive for Both Ki67 and Thymine Dimers | Laser-treated skin | 14.7 positive cells/1000 basal layer cells | Standard Deviation 13.4 |
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.
Time frame: untreated and LaserGenesis treated, three months after treatment
Population: untreated and laser treated biopsies were taken from each subject
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LaserGenesis Treatment | Relative Level of IGF-1 mRNA in the Skin | Untreated skin | 70.5 relative mRNA | Standard Error 22.1 |
| LaserGenesis Treatment | Relative Level of IGF-1 mRNA in the Skin | Laser-treated skin | 115.1 relative mRNA | Standard Error 43.9 |