Spots Global Cancer Trial Database for Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study

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Trial Identification

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

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

Study ID: NCT02150863

Conditions

Extensive Photodamage

Actinic Keratosis

History of Numerous Skin Cancers

Interventions

Ultrapulse Carbon Dioxide Laser

Cellutome epidermal harvesting system

Study Description

Brief Summary: 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

Detailed Description: