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

June 10, 2024 updated by: University of California, Davis

Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: A Prospective, Randomized Controlled, Intra-Individual Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

73

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95816
        • University of California, Davis - Dermatology Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cryotherapy and 5-Fluoruracil
Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.
Procedure: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Partial clearance rate
Time Frame: 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
3 months and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete clearance rate
Time Frame: 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
3 months and 12 months
Percent reduction of AK lesions
Time Frame: 3 months and 12 months
Decrease in number AK lesions from baseline within the selected treatment area
3 months and 12 months
Rate of progression to keratinocyte carcinoma
Time Frame: 3 months and 12 months
Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma
3 months and 12 months
Recurrence rate
Time Frame: 3 months and 12 months
Proportion of participants with recurrent or new lesions within the treatment area
3 months and 12 months
Patient satisfaction
Time Frame: 3 months and 12 months
Proportion of patients who would choose the same treatment again and if they would recommend it to others
3 months and 12 months
Health-Related Quality of Life
Time Frame: 3 months and 12 months
Skindex-29 questionnaire
3 months and 12 months
Cosmetic outcome
Time Frame: 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
3 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Daniel Eisen, MD, UC Davis Department of Dermatology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 17, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2164169

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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