5-fluorouracil + Aluminum for Actinic Keratosis

VC
Overseen ByVlad Codrea, MD, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for actinic keratosis (AK), which are rough, scaly patches that can develop into skin cancer. Researchers are testing whether adding Aluminum Chloride Hexahydrate to a common cream for AK, 5-fluorouracil (5-FU), can enhance its effectiveness. Participants will apply two different creams to AKs on either their scalp or forearms to determine which is more effective. Individuals with 4-15 AKs on their scalp or forearms, and no other skin cancers or open wounds in the treatment area, might be suitable candidates. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this potentially groundbreaking treatment.

Will I have to stop taking my current medications?

Yes, you will need to stop using certain medications, such as prescription topical drugs, immunomodulatory or immunosuppressive medicines, chemotherapy, and vitamin A derivatives, at least one month before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that 5-fluorouracil (5-FU) is generally safe and effective for treating actinic keratosis (AK), which are skin spots that could become cancerous. Studies have found that some people may experience skin reactions like redness and irritation while using 5-FU. These reactions are common but usually mild and temporary.

Researchers are testing aluminum chloride hexahydrate (ACH) with 5-FU to see if it enhances the treatment's effectiveness. ACH, often used to stop bleeding from small cuts, is considered safe. However, its use with 5-FU for AK is still under study, and more information is needed to fully understand its safety.

The safety of 5-FU is well-established, and adding ACH is not expected to cause major new safety issues. Since this treatment is still in early testing, further research will help confirm these findings.12345

Why are researchers excited about this trial's treatment?

Researchers are excited about the investigational treatment for actinic keratosis because it combines 5-fluorouracil (5-FU), a standard treatment, with 15% acetyl cysteine (ACH). This combination could enhance the effectiveness of 5-FU by improving its penetration and action on the lesions. Unlike the standard treatment that solely uses 5-FU, this new approach aims to target the lesions more effectively, potentially leading to better outcomes for patients with fewer applications. The addition of ACH is what makes this treatment stand out, offering a potentially more efficient solution for those dealing with actinic keratosis.

What evidence suggests that this trial's treatments could be effective for actinic keratosis?

Research has shown that 5-fluorouracil (5-FU) effectively treats actinic keratoses (AKs), which are rough, scaly patches on the skin caused by sun damage. Studies have found that a 4% 5-FU cream can significantly reduce the number of these skin lesions, making it a good option for those with extensive skin damage. In this trial, participants will apply either a standard 5% 5-FU cream or an investigational cream combining 5% 5-FU with 15% aluminum chloride hexahydrate (ACH) to determine if ACH enhances the treatment's effectiveness. Early results suggest that aluminum may improve the cream's ability to reduce AKs. This combination is being tested to see if it provides better results than 5-FU alone.13678

Who Is on the Research Team?

JK

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.
See 1 more

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
See 2 more

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?

4

Treatment groups

Experimental Treatment

Group I: Split-Scalp: Left SOC / Right InvestigationalExperimental Treatment2 Interventions
Group II: Split-Scalp: Left Investigational / Right SOCExperimental Treatment2 Interventions
Group III: Split-Forearm: Left SOC / Right InvestigationalExperimental Treatment2 Interventions
Group IV: Split-Forearm: Left Investigational / Right SOCExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials
192
Recruited
64,700+

Citations

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

The primary objective of this study is to determine the effectiveness of using aluminum as an augmenting agent in traditional Standard of Care ( ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41598550/

Efficacy of 4% 5-Fluorouracil Cream in the Treatment ...

Conclusions: Based on our analysis, 4% 5-FU cream is an effective and well-tolerated treatment for AKs, particularly in patients with extensive ...

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

The primary objective of this study is to determine the effectiveness of using aluminum as an augmenting agent in traditional Standard of Care ( ...

Efficacy of 4% 5-Fluorouracil Cream in the Treatment ...

Conclusions: Based on our analysis, 4% 5-FU cream is an effective and well-tolerated treatment for AKs, particularly in patients with extensive field ...

5-Fluorouracil 0.5% Cream for Multiple Actinic or Solar ...

The 0.5% 5-FU cream, when applied once daily for 1, 2 or 4 weeks was significantly more effective than the vehicle control group, both in the ...

Intensity of Local Skin Reactions During 5-Fluorouracil ... - PMC

Safety data were included from 397 patients who had received 5-fluorouracil ... Keywords: Actinic keratosis, 5-Fluorouracil, Local skin ...

5-Fluorouracil Skin Reactions Linked to Higher Clearance ...

The severity of skin reactions to the treatment of actinic keratosis with 5-fluorouracil cream 4% was associated with a higher lesion ...

Efficacy and Safety of 5-Fluorouracil 0.5%/Salicylic Acid 10 ...

The objective of this study was to evaluate the efficacy and safety of 5-fluorouracil (5-FU) 0.5%/salicylic acid 10% as field-directed treatment of AK lesions.