5% 5‑fluorouracil with or without 15% aluminum chloride for actinic keratoses

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study

This will see if adding 15% aluminum chloride to 5% 5‑fluorouracil cream helps clear actinic keratoses on the scalp or forearms in adults with 4–15 lesions after one week of treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: West Virginia University (Academic / other)
• Drugs / interventions: Chemotherapy
• Locations: 1 site (Morgantown, West Virginia)
• Trial ID: NCT07401277 on ClinicalTrials.gov

What this trial studies

This single-center Phase 1 study at West Virginia University compares two topical regimens for actinic keratoses: 5% 5‑fluorouracil alone versus 5% 5‑fluorouracil combined with 15% aluminum chloride hexahydrate. Participants aged 50 and older with 4–15 clinically diagnosed AKs on the scalp or forearms will apply the assigned cream for one week. Dermatologists will count lesions and take photographs before and shortly after treatment to document response and monitor safety. The trial is intended to generate early signals about tolerability and short-term lesion clearance rather than provide definitive efficacy results.

Who should consider this trial

Good fit: Adults aged 50 or older with 4–15 clinically diagnosed actinic keratoses on the scalp or forearms, ECOG performance status ≤2, who can provide informed consent and attend visits at WVU are ideal candidates.

Not a fit: People with suspected squamous cell or basal cell carcinoma or open wounds at the treatment site, known allergy to aluminum chloride, recent use of specified topical or systemic therapies, immunosuppression, or those under age 50 are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, adding aluminum chloride could increase short-term clearance of actinic keratoses and reduce the need for additional procedures.

How similar studies have performed: Topical 5‑fluorouracil is an established treatment for actinic keratoses, but combining it with aluminum chloride hexahydrate is a novel approach with little published data on clinical benefit.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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

Where this trial is running

Morgantown, West Virginia

• West Virginia University — Morgantown, West Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Joanna Kolodney, MD — West Virginia University
• Study coordinator: Vlad Codrea, MD, PhD

Conditions Actinic Keratoses