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Enrolling by Invitation

NCT Number: NCT06461442

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

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California, Davis - Dermatology Department

Sacramento, California, 95816, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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. 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

  4. Recurrence rate

    Time frame: 3 months and 12 months

    Proportion of participants with recurrent or new lesions within the treatment area

  5. 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

  6. Health-Related Quality of Life

    Time frame: 3 months and 12 months

    Skindex-29 questionnaire

  7. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 17, 2024
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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