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Actinic Keratoses Treatment with 5-fluorouracil Plus Aluminum

This study is investigating a new way to treat actinic keratoses (rough, scaly spots on the skin caused by sun exposure). Doctors often use a cream called 5-fluorouracil (5-FU) to treat these spots. This study is testing if adding aluminum chloride hexahydrate, a medication used to stop bleeding, can make 5-FU work better. Researchers will compare the standard 5-FU cream to a combination of 5-FU and aluminum chloride. The study aims to see if the combination treatment reduces the number of actinic keratoses more effectively. You may be able to join if you are between 18 and 50 years old and have 4-15 actinic keratoses on your scalp or forearms. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 32 participants to compare two topical treatments for actinic keratoses.
What's involved
Participants will apply a topical treatment twice daily for seven consecutive days to their actinic keratoses.
Compensation
Not stated in the trial record.
Follow-up
The number of actinic keratoses will be measured at baseline, day 8, and day 56 after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07401277

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

Recruiting
PHASE1Ages 18–50InterventionalPrevention
West Virginia University
~32 participants
Updated 2026-04-22 on ClinicalTrials.gov
What's tested:5% 5-fluorouracil (5-FU) powder5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Actinic Keratoses; Baseline
Measured over Baseline
+2 more outcomes measured

Conditions

Actinic Keratoses

Explore related trials

Actinic Keratosis

NCT07401277

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • West Virginia University

    Morgantown, West Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Joanna Kolodney, MD · PRINCIPAL_INVESTIGATOR · West Virginia University

Who to contact

Vlad Codrea, MD, PhD
[email protected]
304-598-4548
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Less than 50 years due to this being a pathology of adults that develops in chronically sun-damaged skin, individuals \<50 years of age are excluded from this study.
Patients with 4-15 clinically diagnosed AKs on the scalp (16 patients) or on the forearms (16 patients) being followed at the Mohs Surgery clinic by WVU Medicine Dermatology
Performance status: ECOG Performance status less than or equal to 2
Patient must provide informed consent

Exclusion

Presence of a suspected squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) lesion or open wound on the treatment site (scalp or forearm)
History of allergic reactions attributed to compounds of similar chemical or biologic composition to 15% ACH or other agents used in this study
Use of one or more of the following products within the past month:
Tanning skin colorants
Prescription topical drugs
Immunomodulatory or immunosuppressive medicines
Chemotherapy or cytotoxic medications
Photodynamic therapy (PDT) or other treatments of pre-cancers on the skin
Vitamin A derivatives taken by mouth
Patients receiving any other investigational agents
Patients with immunosuppression or weakened immune systems who may be at a higher risk of infection, including patients who have had chronic lymphocytic leukemia (CLL), who have received transplants, or who are taking medications such as chronic steroids or rheumatoid arthritis (RA) drugs

What this trial measures

  • Number of Actinic Keratoses; BaselineBaseline

    Total numerical counts of actinic keratoses (AKs) assessed and documented.

  • Number of Actinic Keratoses; Day 8Day 8

    Total numerical counts of actinic keratoses (AKs) assessed and documented.

  • Number of Actinic Keratoses; Day 56Day 56

    Total numerical counts of actinic keratoses (AKs) assessed and documented.