Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Davis
Dates
study started
completion around
Principal Investigator
by Daniel Eisen, MD (ucdavis)
Headshot of Daniel Eisen
Daniel Eisen

Description

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.

Official Title

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

Keywords

Actinic Keratoses, cryotherapy, 5-Fluorouracil, Actinic Keratosis, Keratosis, Fluorouracil, 5Fluorouracil, Cryotherapy and 5-Fluoruracil

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join 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

Location

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

Lead Scientist at University of California Health

  • Daniel Eisen, MD (ucdavis)
    Professor, Med: Dermatology, School of Medicine. Authored (or co-authored) 134 research publications

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06461442
Phase
Phase 4 Actinic Keratosis Research Study
Study Type
Interventional
Participants
Expecting 73 study participants
Last Updated