Actinic Keratosis, Extensive Photodamage, History of Numerous Skin Cancers
Conditions
Keywords
actinic keratosis, field cancerization, organ transplant patients
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
Interventions
DEVICEUltrapulse Carbon Dioxide Laser
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Count of the Number of Actinic Keratosis and Non Melanoma Skin Cancers in the Treatment Area | Entire study period (3 years) | This is done at every visit over the 3 year period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ultrapulse Laser Alone Ultrapulse Carbon Dioxide Laser | 0 |
| Ultrapulse Laser Plus Cellutome Harvesting System Ultrapulse Carbon Dioxide Laser
Cellutome epidermal harvesting system | 1 |
| Control Control group | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Ultrapulse Laser Plus Cellutome Harvesting System | Total | Ultrapulse Laser Alone |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 70 years | 70 years | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | — |
| Region of Enrollment United States | 1 Participants | 1 Participants | — |
| Sex: Female, Male Female | 1 Participants | 1 Participants | — |
| Sex: Female, Male Male | 0 Participants | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 1 | 0 / 0 |
Outcome results
Primary
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)
Population: Zero participants were analyzed because no patients finished this study. Patient recruitment was very difficult for this study, and therefore the study ended prematurely.