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

October 29, 2019 updated by: Richard Rox Anderson, MD, Massachusetts General Hospital

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria

  1. Subjects with ages between 18 and 85 years, male or female.
  2. Subjects with at least 4 clinically diagnosed actinic keratoses (AKs) per treatment site ( up to 200 sq cm), excluding the face and neck
  3. Subjects with history of at least 1 non-melanoma skin cancer within the past year
  4. Willingness to participate in the study
  5. Informed consent agreement signed by the subject
  6. Willingness to follow the treatment schedule and post treatment care requirements
  7. Willingness to not use topical or systemic (oral) TREATMENT medications including imiquimod, 5-Fluorouracil, photodynamic therapy, during the treatment period.
  8. Has not had treatment for AKs in the treatment area for 4 weeks prior to enrollment

Exclusion criteria

  1. Subjects with active skin cancer in the treatment area. Once the non-melanoma skin cancer has been treated, the subject can be immediately enrolled.
  2. Infection of the area to be treated
  3. An open wound in the area to be treated
  4. Presence of suntan in the area to be treated, or active tanning during the study
  5. Subjects who have taken medication known to induce photosensitivity in the previous 3 months
  6. 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.
  7. Subject is unable to comply with treatment, home care or follow-up visits
  8. Subject is pregnant or breast feeding
  9. Prior use of topical retinoids, 5 fluorouracil, or imiquimod in treated areas within one month of initial treatment
  10. 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;
  11. 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;
  12. Concurrent inflammatory skin conditions, including, but not limited to, eczema, contact dermatitis of any severity;
  13. Active Herpes Simplex at the time of treatment;
  14. Multiple dysplastic nevi in area to be treated;
  15. 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);
  16. 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);
  17. Mentally incompetent, prisoner or evidence of active substance or alcohol abuse;
  18. 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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Active Comparator: Ultrapulse laser alone
Device: Ultrapulse Carbon Dioxide Laser
Other Names:
  • Lumenis Ultrapulse
Active Comparator: Ultrapulse laser plus Cellutome Harvesting system
Device: Ultrapulse Carbon Dioxide Laser
Other Names:
  • Lumenis Ultrapulse
Device: Cellutome epidermal harvesting system

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

  • Principal Investigator: Rox Anderson, MD, Massachusetts General Hospital/ Wellman Center for Photomedicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

March 10, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

October 29, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014P000121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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