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The goal of this clinical trial is to compare the effectiveness and safety of two treatments-cryotherapy and 5-Fluorouracil (5-FU)-for actinic keratosis, a common skin condition caused by long-term sun exposure. Cryotherapy is a treatment that uses extreme cold produced by liquid nitrogen to freeze and destroy abnormal cells, and 5-FU is a topical cream applied to the skin to treat lesions by interfering with cell growth. The main questions this trial aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cryotherapy and 5-Fluoruracil | Experimental | Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cryotherapy | Procedure | Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Partial clearance rate | Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area | 3 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete clearance rate | Proportion of patients with no clinically visible AK lesions (i.e., a 100% reduction in the number of baseline AK lesions) within the selected treatment area | 3 months and 12 months |
| Percent reduction of AK lesions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Eisen, MD | UC Davis Department of Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis - Dermatology Department | Sacramento | California | 95816 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30855743 | Background | Jansen MHE, Kessels JPHM, Nelemans PJ, Kouloubis N, Arits AHMM, van Pelt HPA, Quaedvlieg PJF, Essers BAB, Steijlen PM, Kelleners-Smeets NWJ, Mosterd K. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019 Mar 7;380(10):935-946. doi: 10.1056/NEJMoa1811850. |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017679 | Cryotherapy |
| D005472 | Fluorouracil |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 |
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| 5Fluorouracil | Drug | Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment. |
|
Decrease in number AK lesions from baseline within the selected treatment area
| 3 months and 12 months |
| Rate of progression to keratinocyte carcinoma | Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma | 3 months and 12 months |
| Recurrence rate | Proportion of participants with recurrent or new lesions within the treatment area | 3 months and 12 months |
| Patient satisfaction | Proportion of patients who would choose the same treatment again and if they would recommend it to others | 3 months and 12 months |
| Health-Related Quality of Life | Skindex-29 questionnaire | 3 months and 12 months |
| Cosmetic outcome | The cosmetic outcome will be evaluated using a 4-point scale (1 = excellent, 2 = good, 3 = moderate, and 4 = poor) by an investigator who is blinded to the treatment allocation | 3 months and 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |