Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Neoplasms

Skin Diseases

Precancerous Conditions

Ultrapulse Carbon Dioxide Laser

Cellutome epidermal harvesting system

Rox Anderson, MD

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

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

This is done at every visit over the 3 year period

Massachusetts General Hospital

Harvard Medical School Professor in dermatology, Director of the Wellman Center for Photomedicine; and adjunct Professor of Health Sciences and Technology at MIT

For areas where participants at risk is 0, it is because there were no participants in these categories.

Ultrapulse Laser Alone

Ultrapulse Carbon Dioxide Laser

Cellutome epidermal harvesting system

Ultrapulse Laser Plus Cellutome Harvesting System

Control

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

United States

Region of Enrollment

There was only one patient enrolled in this study

Recruitment was very difficult for this study. Due to long study period, patient retention was also difficult. The study was terminated because of low recruitment. One subject started the study and was lost to follow-up, without completing the study.

Elizabeth Morehouse, Clinical Research Coordinator

Zero participants were analyzed because no patients finished this study. Patient recruitment was very difficult for this study, and therefore the study ended prematurely.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study	NCT02150863	Extensive Photo... Actinic Keratos... History of Nume...	Ultrapulse Carb... Cellutome epide...	18 Years - 85 Years	Massachusetts General Hospital
Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study	NCT02150863	Extensive Photo... Actinic Keratos... History of Nume...	Ultrapulse Carb... Cellutome epide...	18 Years - 85 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for history of numerous skin cancers