NCT07401277

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: West Virginia University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Actinic Keratoses

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2027-07-01
• Completion: 2027-08-01
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study