NCT07401277 Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum
| NCT ID | NCT07401277 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | West Virginia University |
| Condition | Actinic Keratoses |
| Study Type | INTERVENTIONAL |
| Enrollment | 32 participants |
| Start Date | 2026-02-06 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 32 participants in total. It began in 2026-02-06 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is looking at a new way to treat actinic keratoses, which are rough, scaly spots on the skin caused by long-term sun exposure. These spots are common in older adults and, if not treated, can sometimes develop into a type of skin cancer. Doctors often treat areas with many of these spots by using a prescription cream called 5-fluorouracil (5-FU), which helps remove damaged skin cells. This study is testing whether adding aluminum chloride hexahydrate, a medication commonly used to stop bleeding during skin procedures, can improve how well the cream works. People who take part in this study will receive one of two treatments applied to their skin: Standard treatment with 5% 5-fluorouracil cream, or A combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream The treatment will be applied for one week. A dermatologist will examine the treated skin areas, count the number of actinic keratoses, and take photographs before treatment begins, shortly after treatment ends, and again about eight weeks later. These visits help researchers compare how well each treatment reduces the number of skin spots over time. The goal of this study is to learn whether adding aluminum chloride hexahydrate to standard treatment helps reduce actinic keratoses more effectively than standard treatment alone.
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
Contact & Investigator
Joanna Kolodney, MD
PRINCIPAL INVESTIGATOR
West Virginia University
Frequently Asked Questions
Who can join the NCT07401277 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying Actinic Keratoses. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07401277 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07401277 currently recruiting?
Yes, NCT07401277 is actively recruiting participants. Contact the research team at vlad.codrea@hsc.wvu.edu for enrollment information.
Where is the NCT07401277 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT07401277 clinical trial?
NCT07401277 is sponsored by West Virginia University. The principal investigator is Joanna Kolodney, MD at West Virginia University. The trial plans to enroll 32 participants.