Actinic Keratoses
Conditions
Keywords
cryotherapy, 5-Fluorouracil
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.
Interventions
PROCEDURECryotherapy
Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment.
DRUG5Fluorouracil
Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment.
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Recurrence rate | 3 months and 12 months | Proportion of participants with recurrent or new lesions within the treatment area |
| 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 |
| Health-Related Quality of Life | 3 months and 12 months | Skindex-29 questionnaire |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel Eisen, MD
UC Davis Department of Dermatology
Outcome results
None listed