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NCT Number: NCT07401277

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum

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.

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Key information

Conditions

Actinic Keratoses Keratosis Keratosis, Actinic Neoplasms Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

West Virginia University

Morgantown, West Virginia, 26505, United States

Location status: Recruiting

Location contact

Joanna Kolodney, MD

PRINCIPAL_INVESTIGATOR

Vlad Codrea, MD, PhD

CONTACT

[email protected]

304-598-4548

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

5% 5-fluorouracil (5-FU) powder

Drug

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)

Drug

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 outcomes

  1. Number of Actinic Keratoses; Baseline

    Time frame: Baseline

    Total numerical counts of actinic keratoses (AKs) assessed and documented.

  2. Number of Actinic Keratoses; Day 8

    Time frame: Day 8

    Total numerical counts of actinic keratoses (AKs) assessed and documented.

  3. Number of Actinic Keratoses; Day 56

    Time frame: Day 56

    Total numerical counts of actinic keratoses (AKs) assessed and documented.

Secondary outcomes

  1. Skin redness at treatment site(s); Day 8

    Time frame: Day 8

    Redness will be assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema with 0 being the best outcome.

  2. Skin redness at treatment site(s); Day 56

    Time frame: Day 56

    Redness will be assessed using a scale of 0-4 as per the Clinical Erythema Assessment grading scale with: 0 = clear, 1 = almost clear, 2 = mild erythema, 3 = moderate erythema, and 4 = severe erythema with 0 being the best outcome.

  3. Skin itchiness at treatment site(s); Day 8

    Time frame: Day 8

    Itchiness will be assessed using the Peak Pruritus Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no itchiness and 10 being the worst itchiness ever experienced.

  4. Skin itchiness at treatment site(s); Day 56

    Time frame: Day 56

    Itchiness will be assessed using the Peak Pruritus Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no itchiness and 10 being the worst itchiness ever experienced.

  5. Pain at treatment site(s); Day 8

    Time frame: Day 8

    Pain will be assessed using the Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.

  6. Pain at treatment site(s); Day 56

    Time frame: Day 56

    Pain will be assessed using the Numeric Rating Scale (NRS) of 0-10 reported by the patient, with 0 being no pain and 10 being the worst pain ever experienced.

Study contacts

Contact information is provided by the study sponsor or research team.

Vlad Codrea, MD, PhD

CONTACT

[email protected]

304-598-4548

Sponsors and collaborators

Lead sponsor

West Virginia University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 10, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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