Cryotherapy vs 5-Fluorouracil for Actinic Keratosis
What You Need to Know Before You Apply
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.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have used systemic retinoids in the past 3 months, you cannot participate.
Is the combination of cryotherapy and 5-fluorouracil safe for treating actinic keratosis?
How does the treatment of actinic keratosis with cryotherapy and 5-fluorouracil differ from other treatments?
The combination of cryotherapy and 5-fluorouracil (5-FU) is unique because it allows for both targeted and generalized treatment of actinic keratosis (AK), effectively clearing multiple lesions while potentially reducing side effects compared to using cryotherapy alone. This approach is beneficial for patients with numerous AKs, as 5-FU can treat larger areas, and the combination has shown promise in improving clearance rates and tolerability.13678
What data supports the effectiveness of the treatment for actinic keratosis?
Research shows that using cryotherapy combined with 5-fluorouracil cream can effectively clear actinic keratosis lesions for up to 2 months, with fewer side effects compared to cryotherapy alone. Additionally, 5-fluorouracil cream has been shown to be a cost-effective way to manage multiple facial actinic keratosis lesions.136910
Who Is on the Research Team?
Daniel Eisen, MD
Principal Investigator
UC Davis Department of Dermatology
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a baseline assessment where demographics and medical history are recorded, along with the number and severity of actinic keratosis lesions
Treatment
Participants receive both cryotherapy and 5-FU, with each treatment applied to different areas of their body
Follow-up
Participants return to the clinic for follow-up assessments at 3 months and 12 months to monitor for side effects and evaluate treatment outcomes
What Are the Treatments Tested in This Trial?
Interventions
- 5-Fluorouracil
- Cryotherapy
5-Fluorouracil is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Ovarian cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Colorectal cancer
- Breast cancer
- Stomach cancer
- Pancreatic cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Davis
Lead Sponsor