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

NCT06461442 | Enrolling By Invitation Phase 4 FDA Drug

• 1 other identifier: 2164169
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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

Keywords

cryotherapy; 5-Fluorouracil

Outcome Measures

Primary Outcomes (1)

• Partial clearance rate

  Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area

  3 months and 12 months

Secondary Outcomes (7)

• Complete clearance rate

  3 months and 12 months

• Percent reduction of AK lesions

  3 months and 12 months

• Rate of progression to keratinocyte carcinoma

  3 months and 12 months

• Recurrence rate

  3 months and 12 months

• Patient satisfaction

  3 months and 12 months

Study Arms (1)

Cryotherapy and 5-Fluoruracil

EXPERIMENTAL

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

Procedure: Cryotherapy; Drug: 5Fluorouracil

Interventions

Cryotherapy 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.

Cryotherapy and 5-Fluoruracil

5Fluorouracil 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.

Cryotherapy and 5-Fluoruracil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

Location

Related Publications (1)

• 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.

  PMID: 30855743 BACKGROUND

MeSH Terms

Conditions

Keratosis, Actinic

Interventions

Cryotherapy; Fluorouracil

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Daniel Eisen, MD

  UC Davis Department of Dermatology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 17, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Locations

US (1)