Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

Enrolling by invitation · Phase 4

Conditions studied: Actinic Keratoses

In brief

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.

Key facts

Study ID

NCT06461442

Run by

University of California, Davis

People needed

73

Starts

2024-07-01

Expected to finish

2026-09-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18 years of age or older
• Has a clinical diagnosis of 10 or more AKs in the head, neck, or extremities areas
• Able to give informed consent themselves
• Willing to return for follow up visits

You may not qualify if…

• Cognitively Impaired
• Incarcerated
• Non-English speakers
• Immuno-comprised status
• Received any kind of treatment for AK within the past 2 months
• Use of systemic retinoids within the past 3 months
• Suspicion of cancer in the target area
• Porphyria
• Genetic skin cancer disorders
• Allergy to trial drugs or peanut/soy products
• Pregnancy or breast-feeding

Where it is running

• University of California, Davis - Dermatology Department — Sacramento, California, United States

Full record on ClinicalTrials.gov

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