← Back to Search

Anti-metabolites

Cryotherapy vs 5-Fluorouracil for Actinic Keratosis

Phase 4
Waitlist Available
Led By Daniel Eisen, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
Has a clinical diagnosis of 10 or more AKs in the head, neck, or extremities areas
Must not have
Genetic skin cancer disorders
Use of systemic retinoids within the past 3 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 12 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Drug Has Already Been Approved

Summary

"This trial aims to compare two treatments, cryotherapy and 5-Fluorouracil (5-FU), for actinic keratosis, a skin condition caused by sun exposure.

Who is the study for?
This trial is for individuals with actinic keratosis, a skin condition from long-term sun exposure. Participants will have their demographics and medical history recorded and must be willing to receive both cryotherapy and 5-Fluorouracil on different body areas, complete weekly surveys, and return for follow-ups.
What is being tested?
The trial compares the effectiveness of cryotherapy (freezing abnormal cells) versus 5-Fluorouracil cream (interfering with cell growth) in treating actinic keratosis. It assesses which reduces lesions better and evaluates side effects, patient satisfaction, cosmetic outcomes, and quality of life.
What are the potential side effects?
Cryotherapy may cause pain at the treatment site or changes in skin pigmentation. The topical cream 5-Fluorouracil can result in redness, irritation, burning sensation at the application area or increased sensitivity to sunlight.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I have been diagnosed with 10 or more AKs on my head, neck, or limbs.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a genetic condition that causes skin cancer.
Select...
I haven't taken any systemic retinoids in the last 3 months.
Select...
I have porphyria.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Partial clearance rate
Secondary study objectives
Complete clearance rate
Cosmetic outcome
Health-Related Quality of Life
+4 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Cryotherapy and 5-FluoruracilExperimental Treatment2 Interventions
Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryotherapy
2011
Completed Phase 4
~2240
5Fluorouracil
2020
Completed Phase 3
~900

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,615 Total Patients Enrolled
Daniel Eisen, MDPrincipal InvestigatorUC Davis Department of Dermatology
10 Previous Clinical Trials
554 Total Patients Enrolled
~49 spots leftby Jun 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top