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TerminatedNCT02150863Updated Nov 18, 2019Results posted

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

An interventional study of Ultrapulse Carbon Dioxide Laser and Cellutome epidermal harvesting system in Extensive Photodamage, Actinic Keratosis and History of Numerous Skin Cancers, sponsored by Massachusetts General Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-11-18.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficulty enrolling participants due to exclusion and inclusion criteria
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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

02

Conditions studied

  • Extensive Photodamage
  • Actinic Keratosis
  • History of Numerous Skin Cancers

Keywords

  • actinic keratosis
  • field cancerization
  • organ transplant patients
03

In context

Keratosis, Actinic

364 studies on the registry are indexed under Keratosis, Actinic; 31 are open to participants now.

This study's enrollment of 1 is below the median of 60 across 315 interventional studies indexed under Keratosis, Actinic.

Browse Keratosis, Actinic studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Single (Outcomes assessor)
Enrollment
1 participant (actual)

Study arms

  • Active comparator
    Ultrapulse laser alone

    Device: Ultrapulse Carbon Dioxide Laser

  • Active comparator
    Ultrapulse laser plus Cellutome Harvesting system

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

  • No intervention
    Control

Interventions

  • DeviceUltrapulse Carbon Dioxide Laser

    Also known as: Lumenis Ultrapulse

  • DeviceCellutome epidermal harvesting system
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What researchers measure

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

    Time frame: Entire study period (3 years)

07

Results

Posted Nov 18, 2019
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.

Participant flow

Participant flow — Overall Study
MilestoneUltrapulse Laser AloneUltrapulse Laser Plus Cellutome Harvesting SystemControl
Started010
Completed000
Not completed010
Withdrew: Lost to follow-up010

Outcome measures

PrimaryCount 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

Time frame:
Entire study period (3 years)

No measurements were reported for this outcome.

Adverse events

Collected over The time the patient was in the study, 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ultrapulse Laser Alone———
Ultrapulse Laser Plus Cellutome Harvesting System0/1 (0%)0/1 (0%)0/1 (0%)
Control———

Baseline characteristics

There was only one patient enrolled in this study

Age, Categorical
Age, Categorical(Participants)Ultrapulse Laser AloneUltrapulse Laser Plus Cellutome Harvesting SystemControlTotal
<=18 years00—0
Between 18 and 65 years00—0
>=65 years01—1
Age, Continuous
Age, Continuous(years)Ultrapulse Laser AloneUltrapulse Laser Plus Cellutome Harvesting SystemControlTotal
Mean—70—70
Sex: Female, Male
Sex: Female, Male(Participants)Ultrapulse Laser AloneUltrapulse Laser Plus Cellutome Harvesting SystemControlTotal
Female—1—1
Male—0—0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Ultrapulse Laser AloneUltrapulse Laser Plus Cellutome Harvesting SystemControlTotal
Hispanic or Latino—0—0
Not Hispanic or Latino—1—1
Unknown or Not Reported—0—0
Region of Enrollment
Region of Enrollment(Participants)Ultrapulse Laser AloneUltrapulse Laser Plus Cellutome Harvesting SystemControlTotal
United States—1—1
08

Study locations

1 site
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
09

References and documents

Study documents

  • Study protocol · Dec 28, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02150863
Lead sponsor
Massachusetts General Hospital
Responsible party
Richard Rox Anderson, MD (Harvard Medical School Professor in dermatology, Director of the Wellman Center for Photomedicine; and adjunct Professor of Health Sciences and Technology at MIT, Massachusetts General Hospital) — Principal investigator
First posted
May 30, 2014
Start date
Aug 2014
Primary completion
Apr 2018
Completion
Apr 2018
Results posted
Nov 18, 2019
Last update
Nov 18, 2019

Study contacts

Rox Anderson, MD
principal investigator · Massachusetts General Hospital/ Wellman Center for Photomedicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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