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

NCT02150863 | Terminated Results DMC

• 1 other identifier: 2014P000121
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Extensive Photodamage; Actinic Keratosis; History of Numerous Skin Cancers

Keywords

actinic keratosis; field cancerization; organ transplant patients

Outcome Measures

Primary Outcomes (1)

• Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area

  This is done at every visit over the 3 year period

  Entire study period (3 years)

Study Arms (3)

Ultrapulse laser alone

ACTIVE COMPARATOR

Device: Ultrapulse Carbon Dioxide Laser

Ultrapulse laser plus Cellutome Harvesting system

ACTIVE COMPARATOR

Device: Ultrapulse Carbon Dioxide Laser; Device: Cellutome epidermal harvesting system

Control

NO INTERVENTION

Interventions

Ultrapulse Carbon Dioxide Laser DEVICE

Also known as: Lumenis Ultrapulse

Ultrapulse laser alone; Ultrapulse laser plus Cellutome Harvesting system

Cellutome epidermal harvesting system DEVICE

Ultrapulse laser plus Cellutome Harvesting system

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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);

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Elizabeth Morehouse, Clinical Research Coordinator
• Organization: Massachusetts General Hospital

emorehouse@partners.org

617-724-2168

Study Officials

• Rox Anderson, MD

  Massachusetts General Hospital/ Wellman Center for Photomedicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Harvard Medical School Professor in dermatology, Director of the Wellman Center for Photomedicine; and adjunct Professor of Health Sciences and Technology at MIT

Study Record Dates

• First Submitted: March 10, 2014
• First Posted: May 30, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Locations

US (1)