Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
- Registration Number
- NCT06461442
- Lead Sponsor
- University of California, Davis
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 73
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cryotherapy and 5-Fluoruracil 5Fluorouracil Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment. Cryotherapy and 5-Fluoruracil Cryotherapy Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.
- Primary Outcome Measures
Name Time Method Partial clearance rate 3 months and 12 months Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area
- Secondary Outcome Measures
Name Time Method Recurrence rate 3 months and 12 months Proportion of participants with recurrent or new lesions within the treatment area
Health-Related Quality of Life 3 months and 12 months Skindex-29 questionnaire
Patient satisfaction 3 months and 12 months Proportion of patients who would choose the same treatment again and if they would recommend it to others
Cosmetic outcome 3 months and 12 months 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
Complete clearance rate 3 months and 12 months 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
Percent reduction of AK lesions 3 months and 12 months Decrease in number AK lesions from baseline within the selected treatment area
Rate of progression to keratinocyte carcinoma 3 months and 12 months Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma
Trial Locations
- Locations (1)
University of California, Davis - Dermatology Department
🇺🇸Sacramento, California, United States