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Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

NCT07401277 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-04-22

No results posted yet for this study

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.

Conditions

  • Actinic Keratoses

Interventions

DRUG

5% 5-fluorouracil (5-FU) powder

Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen.

DRUG

5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)

Investigational topical combination of fluorouracil 5% and acetyl cysteine 15%, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Joanna Kolodney, MD · West Virginia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-06
Primary Completion
2027-07-31
Completion
2027-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07401277 on ClinicalTrials.gov