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

Study Overview
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Brief Summary
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This project aims to treat field cancerization ( pre-skin cancers) in a manner that will reduce the future pre-skin cancers and non-melanoma skin cancers in patients with significant photodamage. This is 3 year prospective, randomized, controlled comparison of a single treatment with carbon dioxide laser resurfacing vs. carbon dioxide resurfacing plus autologous epidermal skin graft from a non sun exposed site vs. control. Thirty subjects will receive treatment with each of the modalities. The primary measures of efficacy are (a) count of the number of actinic keratosis and non melanoma skin cancers, (b) blinded evaluation of severity from standard digital photographs taken before and after the treatments, and (c) change in histology before and after treatment. Safety measures include (a) pain, (b) scarring, (c) wound healing, (d) and infection

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

Conditions
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Extensive Photodamage, Actinic Keratosis, History of Numerous Skin Cancers

Intervention / Treatment
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* Device: Ultrapulse Carbon Dioxide Laser
* Device: Cellutome epidermal harvesting system


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Subjects with ages between 18 and 85 years, male or female. Subjects with at least 4 clinically diagnosed actinic keratoses (AKs) per treatment site ( up to 200 sq cm), excluding the face and neck Subjects with history of at least 1 non-melanoma skin cancer within the past year Willingness to participate in the study Informed consent agreement signed by the subject Willingness to follow the treatment schedule and post treatment care requirements Willingness to not use topical or systemic (oral) TREATMENT medications including imiquimod, 5-Fluorouracil, photodynamic therapy, during the treatment period. Has not had treatment for AKs in the treatment area for 4 weeks prior to enrollment Exclusion criteria Subjects with active skin cancer in the treatment area. Once the non-melanoma skin cancer has been treated, the subject can be immediately enrolled. Infection of the area to be treated An open wound in the area to be treated Presence of suntan in the area to be treated, or active tanning during the study Subjects who have taken medication known to induce photosensitivity in the previous 3 months 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. Subject is unable to comply with treatment, home care or follow-up visits Subject is pregnant or breast feeding Prior use of topical retinoids, 5 fluorouracil, or imiquimod in treated areas within one month of initial treatment 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; 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; Concurrent inflammatory skin conditions, including, but not limited to, eczema, contact dermatitis of any severity; Active Herpes Simplex at the time of treatment; Multiple dysplastic nevi in area to be treated; 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); 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); Mentally incompetent, prisoner or evidence of active substance or alcohol abuse; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrapulse laser alone<br> | Device: Ultrapulse Carbon Dioxide Laser<br> <br> * Other names: Lumenis Ultrapulse;|
| Active Comparator: Ultrapulse laser plus Cellutome Harvesting system<br> | Device: Ultrapulse Carbon Dioxide Laser<br> <br> * Other names: Lumenis Ultrapulse;Device: Cellutome epidermal harvesting system<br> <br> |
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area | This is done at every visit over the 3 year period | Entire study period (3 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratosis, field cancerization, organ transplant patients