Actinic KeratosesPhase 4NCT06461442
Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis
A Phase 4 study testing Cryotherapy and 5Fluorouracil in people with Actinic Keratoses, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- Cryotherapy and 5Fluorouracil
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 1 Sep 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Suspicion of cancer in the target area
- Porphyria
- Genetic skin cancer disorders
- Allergy to trial drugs or peanut/soy products
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Davis - Dermatology Department
Sacramento, California, 95816
About this study
Official title: 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?
Read more
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.
- Conditions
- Actinic Keratoses
- Being tested
- Cryotherapy, 5Fluorouracil
- Keywords
- cryotherapy, 5-Fluorouracil
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Extremely cold liquid (liquid nitrogen) will used by a dermatologist to freeze and destroy abnormal cells in the treatment areas randomized to this treatment.
5FluorouracilDrug
Patients will apply 5% 5-Fluorouracil cream in a thin layer twice daily for 4 weeks on the treatment areas randomized to this treatment.
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy and 5-Fluoruracil | Experimental | Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment. Receives: Procedure: Cryotherapy; Drug: 5Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial clearance rate
Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area
Measured: 3 months and 12 months
Secondary outcomes (7)
Complete clearance rate
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
Measured: 3 months and 12 months
Percent reduction of AK lesions
Decrease in number AK lesions from baseline within the selected treatment area
Measured: 3 months and 12 months
Rate of progression to keratinocyte carcinoma
Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma
Measured: 3 months and 12 months
Recurrence rate
Proportion of participants with recurrent or new lesions within the treatment area
Measured: 3 months and 12 months
Patient satisfaction
Proportion of patients who would choose the same treatment again and if they would recommend it to others
Measured: 3 months and 12 months
Health-Related Quality of Life
Skindex-29 questionnaire
Measured: 3 months and 12 months
Cosmetic outcome
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
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Eisen, MD, Principal investigator, UC Davis Department of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461442
- Sponsor's protocol ID
- 2164169
- Status last verified
- Jul 2026
- First submitted
- 10 Jun 2024
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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.
PubMed 30855743