NCT02150863

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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

Conditions

• Extensive Photodamage
• Actinic Keratosis
• History of Numerous Skin Cancers

Interventions

Type	Name	Description
DEVICE	Ultrapulse Carbon Dioxide Laser
DEVICE	Cellutome epidermal harvesting system

Timeline

• Start date: 2014-08-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2014-05-30
• Last updated: 2019-11-18
• Results posted: 2019-11-18

Locations

1 site across 1 country: United States