Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
NCT Number: NCT06461442
Status: ENROLLING_BY_INVITATION
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Actinic Keratoses
Interventions: PROCEDURE: Cryotherapy|DRUG: 5Fluorouracil
Sponsor: University of California, Davis
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 73
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2026-06-01
Locations: University of California, Davis - Dermatology Department, Sacramento, California, 95816, United States

Summary:
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.

Primary Outcome Measures: 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
Secondary Outcome Measures: 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, 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