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

NCT ID: NCT06461442

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 73 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-06-01

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.

Conditions

Actinic Keratoses

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cryotherapy and 5-Fluoruracil

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

Group Type: EXPERIMENTAL

Cryotherapy

Intervention Type: PROCEDURE

Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment.

5Fluorouracil

Intervention Type: DRUG

Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment.

Interventions

Cryotherapy

Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment.

Intervention Type: PROCEDURE

5Fluorouracil

Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Daniel Eisen, MD

Role: PRINCIPAL_INVESTIGATOR

UC Davis Department of Dermatology

Locations

University of California, Davis - Dermatology Department

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 30855743 (View on PubMed)

Other Identifiers

2164169

Identifier Type: -

Identifier Source: org_study_id