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: * Which treatment, cryotherapy or 5-FU, is more effective in reducing the number of actinic keratosis lesions? * What are the side effects associated with each treatment? * How do these treatments impact patient satisfaction, cosmetic outcomes, and health-related quality of life? Participants will: * Undergo a baseline assessment where their demographics information such as age, sex, race, smoking status, and medical history are recorded, along with the number and severity of actinic keratosis lesions. * Receive both cryotherapy and 5-FU, with each treatment applied to different areas of their body. The area of the body to receive each treatment is decided by a random process (like flipping a coin). * Complete weekly surveys to monitor for side effects during and after the treatment period. * Return to the clinic for follow-up assessments at 3 months and 12 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
73
Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment.
Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment.
University of California, Davis - Dermatology Department
Sacramento, California, United States
Partial clearance rate
Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area
Time frame: 3 months and 12 months
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
Time frame: 3 months and 12 months
Percent reduction of AK lesions
Decrease in number AK lesions from baseline within the selected treatment area
Time frame: 3 months and 12 months
Rate of progression to keratinocyte carcinoma
Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma
Time frame: 3 months and 12 months
Recurrence rate
Proportion of participants with recurrent or new lesions within the treatment area
Time frame: 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
Time frame: 3 months and 12 months
Health-Related Quality of Life
Skindex-29 questionnaire
Time frame: 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
Time frame: 3 months and 12 months
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