Extensive PhotodamageNCT02150863

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

A study testing Ultrapulse Carbon Dioxide Laser and Cellutome epidermal harvesting system in people with Extensive Photodamage and Actinic Keratosis, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Extensive Photodamage, Actinic Keratosis, History of Numerous Skin Cancers
What is being tested?: Ultrapulse Carbon Dioxide Laser and Cellutome epidermal harvesting system
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: Aug 2014to Apr 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

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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;

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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
Being tested: Ultrapulse Carbon Dioxide Laser, Cellutome epidermal harvesting system
Keywords: actinic keratosis, field cancerization, organ transplant patients
Medical subject headings: Keratosis, Actinic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ultrapulse Carbon Dioxide LaserDevice
Also called Lumenis Ultrapulse
Cellutome epidermal harvesting systemDevice

Study groups in NCT02150863
Study group	Role	What they receive
Ultrapulse laser alone	Active comparator	Not described Receives: Device: Ultrapulse Carbon Dioxide Laser
Ultrapulse laser plus Cellutome Harvesting system	Active comparator	Not described Receives: Device: Ultrapulse Carbon Dioxide Laser; Device: Cellutome epidermal harvesting system
Control	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Entire study period (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Apr 2018

First posted30 May 2014 (estimated)
Study startAug 2014
Primary completionApr 2018
Study completionApr 2018

Why it stopped: Difficulty enrolling participants due to exclusion and inclusion criteria

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Extensive PhotodamageStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02150863
Sponsor's protocol ID: 2014P000121
Status last verified: Oct 2019
First submitted: 10 Mar 2014
Last updated: 18 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Field Cancerization for Reduction in Tumor Burden - A Prospective Study
ClinicalTrials.gov ID: NCT02150863
Acronym / sponsor ID: 2014P000121
Conditions: Extensive Photodamage, Actinic Keratosis, History of Numerous Skin Cancers
Keywords: actinic keratosis, field cancerization, organ transplant patients
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty enrolling participants due to exclusion and inclusion criteria
Enrolment: 1 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: Aug 2014
Primary completion: Apr 2018 (actual)
Study completion: Apr 2018 (actual)
First posted: 30 May 2014 (estimated)
Results: Posted 18 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Thirty subjects will receive treatment with each of the modalities.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
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	–

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (18 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ultrapulse Carbon Dioxide LaserAlso: Lumenis Ultrapulse	Device	Ultrapulse laser alone, Ultrapulse laser plus Cellutome Harvesting system
Cellutome epidermal harvesting system	Device	Ultrapulse laser plus Cellutome Harvesting system

Primary outcome

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

Results and safety

Results posted to the registry on 18 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ultrapulse Laser Alone	0	0
Ultrapulse Laser Plus Cellutome Harvesting System	1	0
Control	0	0

Primary outcome: Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area

Time frame: Entire study period (3 years)

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

Adverse events

Time frame: The time the patient was in the study, 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ultrapulse Laser Alone	0 of 0	0 of 0	0
Ultrapulse Laser Plus Cellutome Harvesting System	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Control	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Rox Anderson, MD principal investigator

Massachusetts General Hospital/ Wellman Center for Photomedicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area (time frame: Entire study period (3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02150863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.