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

Mass General Brigham

Status

Terminated

Conditions

Actinic Keratosis

Extensive Photodamage

History of Numerous Skin Cancers

Treatments

Device: Ultrapulse Carbon Dioxide Laser

Device: Cellutome epidermal harvesting system

Study type

Interventional

Funder types

Other

Identifiers

NCT02150863

2014P000121

Details and patient eligibility

About

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

Enrollment

1 patient

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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;