5-fluorouracil + Aluminum for Actinic Keratosis

Overseen By Vlad Codrea, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: West Virginia University

Must not be taking: Immunosuppressives, Chemotherapy, Vitamin A, others

Disqualifiers: SCC, BCC, Immunosuppression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 8 days

What You Need to Know Before You Apply

What is the purpose of this trial?

Actinic keratoses (AKs) are precancerous skin lesions most common among older white individuals and are prevalent throughout West Virginia. There is a risk of progression to cutaneous squamous cell carcinoma (SCC) when lesions are left untreated. Field-directed therapy with topical agents is used for patients with multiple lesions in a contiguous area. We propose that aluminum utilized for hemostasis is a contributing factor in the tumor regression seen after some biopsies and may be effective as an augmenting agent for topical management of AKs. The primary objective of this study is to determine the effectiveness of using aluminum as an augmenting agent in traditional Standard of Care (SOC) topical cream to treat AKs by assessing the response of AKs to treatment with 5% 5-FU plus 15% aluminum chloride hexahydrate (ACH) cream and comparing the reduction in the number/burden of lesions to SOC topical treatment (5% 5-fluorouracil (5-FU)). Photographs and total counts of AKs will be taken by a single dermatologist before (day 0), immediately after (day 8), and 8 weeks after (day 56) treatment.

Who Is on the Research Team?

Joanna Kolodney, MD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

This trial is for older adults with actinic keratoses, which are skin lesions that could turn into a type of skin cancer. Participants should have multiple lesions in one area and must not have used certain other treatments recently.

Inclusion Criteria

Patient must provide informed consent

I can perform daily activities with minimal assistance.

I am under 50 years old.

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to 15% ACH or other agents used in this study

I haven't used any skin colorants, strong skin creams, immune system drugs, cancer treatments, or Vitamin A pills in the last month.

Patients receiving any other investigational agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants apply investigational cream (5% 5-FU + 15% ACH) and SOC cream (5% 5-FU) to AK lesions on the scalp or forearms

8 days

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 5-fluorouracil (5-FU)
• Aluminum Chloride Hexahydrate (ACH)

Trial Overview

The study tests if adding aluminum to a standard cream (5% 5-FU) improves treatment of actinic keratoses. Patients will be compared using just the cream or the cream plus aluminum over an 8-week period, with lesion counts taken at different times.

How Is the Trial Designed?

Group I: Split-Scalp: Left SOC / Right Investigational Experimental Treatment 2 Interventions

Participants clinically diagnosed with AKs on the scalp will apply SOC cream (5% 5-FU) to AK lesions on the left half of the scalp and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating "Container A to right" (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Group II: Split-Scalp: Left Investigational / Right SOC Experimental Treatment 2 Interventions

Participants clinically diagnosed with actinic keratoses (AKs) on the scalp will apply investigational cream (5% 5-fluorouracil \[5-FU\] + 15% acetyl cysteine \[ACH\]) to AK lesions on the left half of the scalp and standard of care (SOC) cream (5% 5-FU) to AK lesions on the right half of the scalp. Assignment is determined by sealed, randomized envelopes indicating "Container A to left" (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Group III: Split-Forearm: Left SOC / Right Investigational Experimental Treatment 2 Interventions

Participants clinically diagnosed with AKs on the forearms will apply SOC cream (5% 5-FU) to AK lesions on the left forearm and investigational cream (5% 5-FU + 15% ACH) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating "Container A to right" (with Container B to left); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Group IV: Split-Forearm: Left Investigational / Right SOC Experimental Treatment 2 Interventions

Participants clinically diagnosed with AKs on the forearms will apply investigational cream (5% 5-FU + 15% ACH) to AK lesions on the left forearm and SOC cream (5% 5-FU) to AK lesions on the right forearm. Assignment is determined by sealed, randomized envelopes indicating "Container A to left" (with Container B to right); the identity of A vs B (SOC vs investigational) is blinded to participants and investigators.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+