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

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

• Partial clearance rate [Time frame: 3 months and 12 months]

Secondary outcome measures (7)

• Complete clearance rate [Time frame: 3 months and 12 months]
• Percent reduction of AK lesions [Time frame: 3 months and 12 months]
• Rate of progression to keratinocyte carcinoma [Time frame: 3 months and 12 months]
• Recurrence rate [Time frame: 3 months and 12 months]
• Patient satisfaction [Time frame: 3 months and 12 months]
• Health-Related Quality of Life [Time frame: 3 months and 12 months]
• Cosmetic outcome [Time frame: 3 months and 12 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of California, Davis - Dermatology Department — Sacramento

Publications

• 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

Identifiers

NCT: NCT06461442 · 2164169

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗