Clinical trial NCT06461442: Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
Official title: Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: A Prospective, Randomized Controlled, Intra-Individual Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE4
Conditions: Actinic Keratoses
Keywords: cryotherapy
5-Fluorouracil
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2024-06-17
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Partial clearance rate
timeFrame: 3 months and 12 months
Secondary outcomes:
measure: Complete clearance rate
timeFrame: 3 months and 12 months
measure: Percent reduction of AK lesions
timeFrame: 3 months and 12 months
measure: Rate of progression to keratinocyte carcinoma
timeFrame: 3 months and 12 months
measure: Recurrence rate
timeFrame: 3 months and 12 months
measure: Patient satisfaction
timeFrame: 3 months and 12 months
measure: Health-Related Quality of Life
timeFrame: 3 months and 12 months
measure: Cosmetic outcome
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California, Davis - Dermatology Department
state: California
Study officials:
affiliation: UC Davis Department of Dermatology
name: Daniel Eisen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jansen MHE, Kessels JPHM, Nelemans PJ, Kouloubis N, Arits AHMM, van Pelt HPA, Quaedvlieg PJF, Essers BAB, Steijlen PM, Kelleners-Smeets NWJ, Mosterd K. Randomized Trial of Four Treatment Approaches for Actinic Keratosis. N Engl J Med. 2019 Mar 7;380(10):935-946. doi: 10.1056/NEJMoa1811850.