Actively Recruiting
Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study
Led by West Virginia University · Updated on 2026-04-22
32
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to find a new way to treat actinic keratoses, which are rough, scaly skin spots caused by long-term sun exposure. These spots are common in adults under 50 with chronically sun-damaged skin and can sometimes develop into skin cancer if untreated. The study is exploring whether adding aluminum chloride hexahydrate to a standard cream treatment improves the reduction of these skin spots. Participants will apply one of two treatments to their affected skin areas: either the standard 5% 5-fluorouracil cream alone or a combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream. The treatment is applied twice daily for one week on either the scalp or forearms. The study uses a split-area approach where one half receives the investigational treatment and the other half receives standard care, with the assignment randomized and blinded. Participants will be examined before treatment, shortly after the one-week treatment ends, and about eight weeks later. During these visits, a dermatologist will count the number of actinic keratoses and take photographs to monitor changes. Researchers will also assess skin redness, itchiness, and pain at the treatment sites. The study will measure how well each treatment reduces the number of skin spots over time and monitor participant safety.
CONDITIONS
Brief Title
Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults younger than 50 years
- Have 4 to 15 clinically diagnosed actinic keratoses on the scalp or forearms
- ECOG Performance status less than or equal to 2
- Able to provide informed consent
You will not qualify if you...
- Suspected squamous cell carcinoma or basal cell carcinoma lesion or open wound on treatment site
- Allergic reactions to aluminum chloride hexahydrate or similar compounds
- Use of tanning skin colorants, prescription topical drugs, immunomodulatory or immunosuppressive medicines, chemotherapy, photodynamic therapy, or oral vitamin A derivatives within the past month
- Receiving other investigational agents
- Immunosuppression or weakened immune system due to conditions such as chronic lymphocytic leukemia, transplants, or use of chronic steroids or rheumatoid arthritis drugs
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants apply topical creams twice daily for seven consecutive days to actinic keratosis lesions on designated areas of the scalp or forearms.
1 baseline visit and 1 follow-up visit
Duration - Up to 49 days after treatment
Participants are monitored for skin redness, itchiness, and pain at treatment sites and actinic keratoses count up to 56 days after treatment.
1 follow-up visit at Day 56
Trial Site Locations
Total: 1 location
1
West Virginia University
Morgantown, West Virginia, United States, 26505
Actively Recruiting
Research Team
V
Vlad Codrea, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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