Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis

University of California (UC) Davis

Status and phase: Invitation-only; Phase 4

Conditions: Actinic Keratoses

Treatments: Drug: 5Fluorouracil; Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06461442

2164169

Details and patient eligibility

About

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.

Enrollment: 73 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Cryotherapy and 5-Fluoruracil

Experimental group

Description:

Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.

Treatment:

Procedure: Cryotherapy

Drug: 5Fluorouracil