Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study

Inclusion criteria

1. Subjects with ages between 18 and 85 years, male or female.

2. Subjects with at least 4 clinically diagnosed actinic keratoses (AKs) per treatment
site ( up to 200 sq cm), excluding the face and neck

3. Subjects with history of at least 1 non-melanoma skin cancer within the past year

4. Willingness to participate in the study

5. Informed consent agreement signed by the subject

6. Willingness to follow the treatment schedule and post treatment care requirements

7. Willingness to not use topical or systemic (oral) TREATMENT medications including
imiquimod, 5-Fluorouracil, photodynamic therapy, during the treatment period.

8. Has not had treatment for AKs in the treatment area for 4 weeks prior to enrollment

Exclusion criteria

1. Subjects with active skin cancer in the treatment area. Once the non-melanoma skin
cancer has been treated, the subject can be immediately enrolled.

2. Infection of the area to be treated

3. An open wound in the area to be treated

4. Presence of suntan in the area to be treated, or active tanning during the study

5. Subjects who have taken medication known to induce photosensitivity in the previous 3
months

6. The patient has any contraindication to use of the carbon dioxide laser, including
but not limited to, intake of isotretinoin in past 12 months; patients with reduced
adnexal structures (eg, scleroderma, irradiation or burns); patients with history of
vitiligo or psoriasis (risk of Koebnerization); history of keloids/hypertrophic
scarring.

7. Subject is unable to comply with treatment, home care or follow-up visits

8. Subject is pregnant or breast feeding

9. Prior use of topical retinoids, 5 fluorouracil, or imiquimod in treated areas within
one month of initial treatment

10. Prior skin treatment with laser or other devices in the treated area within two
months of initial treatment or during the course of the study;

11. Adverse reactions to compounds of any external agent (e.g., gels, lotions or
anesthetic creams) required for use in the study, if no alternative to the said agent
exists;

12. Concurrent inflammatory skin conditions, including, but not limited to, eczema,
contact dermatitis of any severity;

13. Active Herpes Simplex at the time of treatment;

14. Multiple dysplastic nevi in area to be treated;

15. Having a bleeding disorder or taking anticoagulation medications, including heavy use
of aspirin, in a manner which does not allow for a minimum 10 day washout period
prior to each treatment (as per the patient's physician discretion);

16. Significant concurrent illness, such as uncontrolled diabetes, (i.e., any disease
state that in the opinion of the Investigator would interfere with the anesthesia,
treatment, or healing process);

17. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;

18. Any condition which, in the Investigator's opinion, would make it unsafe (for the
subject or study personnel) to treat the subject as part of this research study;