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

Actinic Keratoses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06461442
• Other study ID #: 2164169
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: July 1, 2024
• Est. completion date: June 1, 2026

Study information

• Verified date: June 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 73
• Est. completion date: June 1, 2026
• Est. primary completion date: June 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Actinic Keratoses
• Keratosis
• Keratosis, Actinic

Intervention

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.

Locations

Country	Name	City	State
United States	University of California, Davis - Dermatology Department	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial clearance rate	Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area	3 months and 12 months
Secondary	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	3 months and 12 months
Secondary	Percent reduction of AK lesions	Decrease in number AK lesions from baseline within the selected treatment area	3 months and 12 months
Secondary	Rate of progression to keratinocyte carcinoma	Proportion of AK lesions within the treatment area that progress to keratinocyte carcinoma	3 months and 12 months
Secondary	Recurrence rate	Proportion of participants with recurrent or new lesions within the treatment area	3 months and 12 months
Secondary	Patient satisfaction	Proportion of patients who would choose the same treatment again and if they would recommend it to others	3 months and 12 months
Secondary	Health-Related Quality of Life	Skindex-29 questionnaire	3 months and 12 months
Secondary	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	3 months and 12 months