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Trial Title:
Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
NCT ID:
NCT06461442
Condition:
Actinic Keratoses
Conditions: Official terms:
Keratosis, Actinic
Keratosis
Fluorouracil
Conditions: Keywords:
cryotherapy
5-Fluorouracil
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Cryotherapy
Description:
Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and
destroy abnormal cells in the treatment areas randomized to this treatment.
Arm group label:
Cryotherapy and 5-Fluoruracil
Intervention type:
Drug
Intervention name:
5Fluorouracil
Description:
Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on
the treatment areas randomized to this treatment.
Arm group label:
Cryotherapy and 5-Fluoruracil
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California, Davis - Dermatology Department
Address:
City:
Sacramento
Zip:
95816
Country:
United States
Start date:
July 1, 2024
Completion date:
June 1, 2026
Lead sponsor:
Agency:
University of California, Davis
Agency class:
Other
Source:
University of California, Davis
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06461442
