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New treatment option for Actinic Keratoses
Official title Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum
ClinicalTrials.gov ID: NCT07401277
What this study is testing
What is 5% 5-fluorouracil (5-FU) powder?
5% 5-fluorouracil (5-FU) powder is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for actinic keratoses.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50
You may be able to join if
- 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...
- 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...
- Performance status: ECOG Performance status less than or equal to 2
- Patient must provide informed consent
You likely can't join if
- 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
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Morgantown, West Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Morgantown, West Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.