Recruiting
Phase 1

5-FU & Aluminum Chloride

Sponsor:

West Virginia University

Code:

NCT07401277

Conditions

Actinic Keratoses

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

5% 5-fluorouracil (5-FU) powder

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

Study Details

Brief 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

Study ID

NCT07401277

Start date

Feb 6, 2026

Status verified date

Dec, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Less than 50 years due to this being a pathology of adults that develops in chronically sun-damaged skin, individuals <50 years of age are excluded from this study.
  • Patients with 4-15 clinically diagnosed AKs on the scalp (16 patients) or on the forearms (16 patients) being followed at the Mohs Surgery clinic by WVU Medicine Dermatology
  • Performance status: ECOG Performance status less than or equal to 2
  • Patient must provide informed consent

Exclusion Criteria:

  • Presence of a suspected squamous cell carcinoma (SCC) or basal cell carcinoma (BCC) lesion or open wound on the treatment site (scalp or forearm)
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 15% ACH or other agents used in this study
  • Use of one or more of the following products within the past month:

  • Tanning skin colorants
  • Prescription topical drugs
  • Immunomodulatory or immunosuppressive medicines
  • Chemotherapy or cytotoxic medications
  • Photodynamic therapy (PDT) or other treatments of pre-cancers on the skin
  • Vitamin A derivatives taken by mouth
  • Patients receiving any other investigational agents
  • Patients with immunosuppression or weakened immune systems who may be at a higher risk of infection, including patients who have had chronic lymphocytic leukemia (CLL), who have received transplants, or who are taking medications such as chronic steroids or rheumatoid arthritis (RA) drugs

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Split-Scalp: Left Investigational / Right SOC

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.

experimental: Split-Scalp: Left SOC / Right Investigational

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.

experimental: Split-Forearm: Left Investigational / Right SOC

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.

experimental: Split-Forearm: Left SOC / Right Investigational

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.

Interventions

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.

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.

Primary outcome measure

  • Number of Actinic Keratoses; Baseline [ Time Frame: Baseline ]
  • Number of Actinic Keratoses; Day 8 [ Time Frame: Day 8 ]
  • Number of Actinic Keratoses; Day 56 [ Time Frame: Day 56 ]

Central Contacts and Locations

Central contacts

Vlad Codrea, MD, PhD

304-598-4548vlad.codrea@hsc.wvu.edu

Locations

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26505

Contacts

Vlad Codrea, MD, PhD

304-598-4548vlad.codrea@hsc.wvu.edu

Principal Investigator:

Joanna Kolodney, MD

More Information

Sponsor

West Virginia University

Last update posted

Apr 22, 2026

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-04-22.