Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
NCT07401277

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

Led by West Virginia University · Updated on 2026-04-22

32

Participants Needed

1

Research Sites

77 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 50 years
  • 4 to 15 clinically diagnosed actinic keratoses on scalp or forearms
  • Follow-up at WVU Medicine Dermatology Mohs Surgery clinic
  • ECOG Performance Status of 2 or less
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Presence of suspected squamous cell carcinoma, basal cell carcinoma, or open wound on treatment site
  • Allergic reactions to 15% aluminum chloride hexahydrate or similar compounds
  • Use of tanning skin colorants, prescription topical drugs, immunomodulatory or immunosuppressive medicines, chemotherapy, photodynamic therapy, or oral vitamin A derivatives in past month
  • Receiving other investigational agents
  • Immunosuppression or weakened immune system from conditions like chronic lymphocytic leukemia, transplants, or medications such as chronic steroids or rheumatoid arthritis drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

West Virginia University

Morgantown, West Virginia, United States, 26505

Actively Recruiting

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Research Team

V

Vlad Codrea, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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