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

Not Applicable

Terminated

• Conditions: Extensive Photodamage; Actinic Keratosis; History of Numerous Skin Cancers
• Interventions: Device: Ultrapulse Carbon Dioxide Laser; Device: Cellutome epidermal harvesting system

• Registration Number: NCT02150863
• Lead Sponsor: Massachusetts General Hospital

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

Not available

Study Timeline

• Study First Submitted: 2014-03-10
• Study First Submitted QC: 2014-05-29
• Study First Posted: 2014-05-30
• Study Start: 2014-08
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-10
• Results First Submitted: 2019-10-11
• Results First Submitted QC: 2019-10-29
• Last Update Submitted: 2019-10-29
• Results First Posted: 2019-11-18
• Last Update Posted: 2019-11-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrapulse laser alone	Ultrapulse Carbon Dioxide Laser	-
Ultrapulse laser plus Cellutome Harvesting system	Ultrapulse Carbon Dioxide Laser	-
Ultrapulse laser plus Cellutome Harvesting system	Cellutome epidermal harvesting system	-

Primary Outcome Measures

Name	Time	Method
Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area	Entire study period (3 years)	This is done at every visit over the 3 year period

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States