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
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
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 →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.
Exclusion criteria
Device: Ultrapulse Carbon Dioxide Laser
Device: Ultrapulse Carbon Dioxide Laser · Device: Cellutome epidermal harvesting system
Also known as: Lumenis Ultrapulse
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)
| Milestone | Ultrapulse Laser Alone | Ultrapulse Laser Plus Cellutome Harvesting System | Control |
|---|---|---|---|
| Started | 0 | 1 | 0 |
| Completed | 0 | 0 | 0 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
This is done at every visit over the 3 year period
No measurements were reported for this outcome.
Collected over The time the patient was in the study, 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ultrapulse Laser Alone | — | — | — |
| Ultrapulse Laser Plus Cellutome Harvesting System | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Control | — | — | — |
There was only one patient enrolled in this study
| Age, Categorical(Participants) | Ultrapulse Laser Alone | Ultrapulse Laser Plus Cellutome Harvesting System | Control | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | — | 0 |
| Between 18 and 65 years | 0 | 0 | — | 0 |
| >=65 years | 0 | 1 | — | 1 |
| Age, Continuous(years) | Ultrapulse Laser Alone | Ultrapulse Laser Plus Cellutome Harvesting System | Control | Total |
|---|---|---|---|---|
| Mean | — | 70 | — | 70 |
| Sex: Female, Male(Participants) | Ultrapulse Laser Alone | Ultrapulse Laser Plus Cellutome Harvesting System | Control | Total |
|---|---|---|---|---|
| Female | — | 1 | — | 1 |
| Male | — | 0 | — | 0 |
| Ethnicity (NIH/OMB)(Participants) | Ultrapulse Laser Alone | Ultrapulse Laser Plus Cellutome Harvesting System | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | — | 0 | — | 0 |
| Not Hispanic or Latino | — | 1 | — | 1 |
| Unknown or Not Reported | — | 0 | — | 0 |
| Region of Enrollment(Participants) | Ultrapulse Laser Alone | Ultrapulse Laser Plus Cellutome Harvesting System | Control | Total |
|---|---|---|---|---|
| United States | — | 1 | — | 1 |
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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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Massachusetts General Hospital