Cryotherapy vs 5-Fluorouracil for Actinic Keratosis

Recruiting in Palo Alto (17 mi)

Daniel Eisen - UC Davis Department of ...

Overseen byDaniel Eisen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for individuals with actinic keratosis, a skin condition from long-term sun exposure. Participants will have their demographics and medical history recorded and must be willing to receive both cryotherapy and 5-Fluorouracil on different body areas, complete weekly surveys, and return for follow-ups.

Inclusion Criteria

I am 18 years old or older.

Able to give informed consent themselves

Willing to return for follow up visits

+1 more

Exclusion Criteria

Immuno-comprised status

Allergy to trial drugs or peanut/soy products

Incarcerated

+8 more

Participant Groups

The trial compares the effectiveness of cryotherapy (freezing abnormal cells) versus 5-Fluorouracil cream (interfering with cell growth) in treating actinic keratosis. It assesses which reduces lesions better and evaluates side effects, patient satisfaction, cosmetic outcomes, and quality of life.

1Treatment groups

Experimental Treatment

Group I: Cryotherapy and 5-FluoruracilExperimental Treatment2 Interventions

Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.

5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as 5-FU for: