Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2026
CompletedStudy Start
First participant enrolled
February 6, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 22, 2026
December 1, 2025
1.4 years
February 3, 2026
April 17, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Number of Actinic Keratoses; Baseline
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Baseline
Number of Actinic Keratoses; Day 8
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Day 8
Number of Actinic Keratoses; Day 56
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Day 56
Secondary Outcomes (6)
Skin redness at treatment site(s); Day 8
Day 8
Skin redness at treatment site(s); Day 56
Day 56
Skin itchiness at treatment site(s); Day 8
Day 8
Skin itchiness at treatment site(s); Day 56
Day 56
Pain at treatment site(s); Day 8
Day 8
- +1 more secondary outcomes
Study Arms (4)
Split-Scalp: Left Investigational / Right SOC
EXPERIMENTALParticipants 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.
Split-Scalp: Left SOC / Right Investigational
EXPERIMENTALParticipants 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.
Split-Forearm: Left Investigational / Right SOC
EXPERIMENTALParticipants 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.
Split-Forearm: Left SOC / Right Investigational
EXPERIMENTALParticipants 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
Standard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Virginia University
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joanna Kolodney, MD
West Virginia University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Containers labeled A or B; identity of SOC 5% 5-FU vs investigational 5% 5-FU + 15% ACH concealed from participants and investigators.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 3, 2026
First Posted
February 10, 2026
Study Start
February 6, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 22, 2026
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share