Cryotherapy vs 5-Fluorouracil for Actinic Keratosis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines two treatments, cryotherapy and 5-Fluorouracil (5-FU), to determine which is more effective for actinic keratosis, a skin condition caused by excessive sun exposure. Cryotherapy uses extreme cold to freeze and remove damaged cells, while 5-FU is a cream that inhibits the growth of these cells. The researchers aim to identify which treatment better reduces skin spots, their side effects, and their impact on patients' perceptions of their skin and quality of life. This trial suits individuals with 10 or more actinic keratosis spots on their head, neck, or limbs. Participants will apply both treatments to different body areas to compare results. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, providing insight into their benefits for more patients.
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.
What is the safety track record for cryotherapy and 5-Fluorouracil?
A previous study found that a cream with 4% 5-fluorouracil (5-FU) was both effective and safe for people with actinic keratosis. This cream effectively reduced skin lesions and was generally easy for users to tolerate. Some experienced side effects, such as skin irritation, but these were usually mild.
Research has also shown that cryotherapy is a well-tolerated option for treating actinic keratosis. This treatment uses extreme cold to freeze and remove abnormal skin cells. Most people manage the treatment well, although some might feel discomfort or notice changes in their skin afterward.
Both treatments have been used for a long time and have good safety records. Patients should still monitor their condition during treatment and report any issues to their doctor.12345Why are researchers enthusiastic about this study treatment?
Most treatments for actinic keratosis, like cryotherapy, involve freezing the lesions, which can be painful and may require recovery time. However, 5-Fluorouracil offers a different approach by using a topical cream that specifically targets and disrupts abnormal cell growth. This method can be less invasive and allows for treatment of larger areas at once. Researchers are excited about the potential for 5-Fluorouracil to provide a more comfortable and effective alternative to traditional treatments, with the added benefit of treating multiple lesions simultaneously.
What evidence suggests that this trial's treatments could be effective for actinic keratosis?
This trial will compare the effectiveness of cryotherapy and 5-Fluorouracil (5-FU) in treating actinic keratosis, a skin condition caused by sun damage. Research has shown that both treatments are effective. Cryotherapy can cure up to 98.8% of cases by using extreme cold to freeze and destroy abnormal skin cells. Meanwhile, 5-FU cream significantly reduces the number of lesions; one study reported a 62.4% reduction after just one week of use. The treatments work differently: cryotherapy provides quick results, while 5-FU offers a more gradual approach. Participants in this trial will receive either cryotherapy or 5-FU for their lesions.16789
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
Trial Overview
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.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
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:
- 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
Published Research Related to This Trial
Citations
Evaluating the Efficacy and Safety of 4% 5-Fluorouracil ...
Treatment with 4% 5-fluorouracil cream was highly efficacious, safe, and prevented disease recurrence in approximately 27% of patients who achieved complete ...
Evaluating the Efficacy and Safety of 4% 5-Fluorouracil ...
This narrative review discusses data on 4% 5-fluorouracil cream to treat actinic keratosis, and provides the authors' expert opinion on issues ...
Pre-treatment with topical 5-fluorouracil increases the ...
Twelve weeks after treatment 87 % of all AKs cleared after 5-FU+dPDT compared to 74 % after dPDT alone (p<0.0001). For grade II AKs, the lesion response rate ...
Effect of a 1-Week Treatment With 0.5% Topical ...
Results At 4 weeks, mean actinic keratosis lesion count was reduced by 62.4% in the 0.5% fluorouracil group vs 28.8% in the vehicle group (P<.001), and complete ...
Calcipotriol and 5-Fluorouracil Combination Therapy for ...
The combination of 5-FU and calcipotriol effectively treats actinic keratosis by enhancing the immune response and targeting cell overgrowth.
Evaluating the Efficacy and Safety of 4% 5-Fluorouracil ...
This narrative review discusses data on 4% 5-fluorouracil cream to treat actinic keratosis, and provides the authors' expert opinion on issues ...
7.
mayoclinic.org
mayoclinic.org/drugs-supplements/fluorouracil-topical-route/description/drg-20063877Fluorouracil (topical route) - Side effects & dosage
Fluorouracil topical is used to treat actinic or solar keratoses and a type of skin cancer called superficial basal cell carcinoma.
EFUDEX® (fluorouracil) TOPICAL SOLUTIONS AND CREAM ...
Actinic or Solar Keratosis: Apply cream or solution twice daily in an amount sufficient to cover the lesions. Medication should be continued ...
Evaluation of the efficacy and tolerability of 0.5% ...
Results: Treatment with 0.5% fluorouracil cream reduced the number of AK lesions from 11.3 at baseline to 2.5 at the end of the 4-week follow-up phase, compared ...
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