Actinic KeratosesPhase 1NCT07401277
Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum
A Phase 1 study testing 5% 5-fluorouracil (5-FU) powder and 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) in people with Actinic Keratoses, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Actinic Keratoses
- What is being tested?
- 5% 5-fluorouracil (5-FU) powder and 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2026to Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
West Virginia University
Morgantown, West Virginia, 26505
Vlad Codrea, MD, PhD, 304-598-4548, vlad.codrea@hsc.wvu.edu
Joanna Kolodney, MD
About this study
Official title: Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study
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.
Read more
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
- Being tested
- 5% 5-fluorouracil (5-FU) powder, 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5% 5-fluorouracil (5-FU) powderDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Split-Scalp: Left Investigational / Right SOC | Experimental | 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. Receives: Drug: 5% 5-fluorouracil (5-FU) powder; Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) |
| Split-Scalp: Left SOC / Right Investigational | Experimental | 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. Receives: Drug: 5% 5-fluorouracil (5-FU) powder; Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) |
| Split-Forearm: Left Investigational / Right SOC | Experimental | 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. Receives: Drug: 5% 5-fluorouracil (5-FU) powder; Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) |
| Split-Forearm: Left SOC / Right Investigational | Experimental | 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. Receives: Drug: 5% 5-fluorouracil (5-FU) powder; Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Actinic Keratoses; Baseline
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Measured: Baseline
Number of Actinic Keratoses; Day 8
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Measured: Day 8
Number of Actinic Keratoses; Day 56
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Measured: Day 56
Secondary outcomes (6)
Skin redness at treatment site(s); 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.
Measured: Day 8
Skin redness at treatment site(s); 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.
Measured: Day 56
Skin itchiness at treatment site(s); 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.
Measured: Day 8
Skin itchiness at treatment site(s); 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.
Measured: Day 56
Pain at treatment site(s); 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.
Measured: Day 8
Pain at treatment site(s); 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.
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start6 Feb 2026
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joanna Kolodney, West Virginia University
- Investigators
- Joanna Kolodney, MD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401277
- Sponsor's protocol ID
- 2501092203
- Status last verified
- Dec 2025
- First submitted
- 3 Feb 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum: an Exploratory Study
- ClinicalTrials.gov ID
- NCT07401277
- Acronym / sponsor ID
- 2501092203
- Conditions
- Actinic Keratoses
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Split-Scalp: Left Investigational / Right SOC | Experimental | Drug: 5% 5-fluorouracil (5-FU) powder, Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)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. |
| Split-Scalp: Left SOC / Right Investigational | Experimental | Drug: 5% 5-fluorouracil (5-FU) powder, Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)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. |
| Split-Forearm: Left Investigational / Right SOC | Experimental | Drug: 5% 5-fluorouracil (5-FU) powder, Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)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. |
| Split-Forearm: Left SOC / Right Investigational | Experimental | Drug: 5% 5-fluorouracil (5-FU) powder, Drug: 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5% 5-fluorouracil (5-FU) powderStandard of care topical fluorouracil 5% cream, applied twice daily for seven consecutive days to designated side's AK lesions per protocol regimen. | Drug | Split-Forearm: Left Investigational / Right SOC, Split-Forearm: Left SOC / Right Investigational, Split-Scalp: Left Investigational / Right SOC, Split-Scalp: Left SOC / Right Investigational |
| 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. | Drug | Split-Forearm: Left Investigational / Right SOC, Split-Forearm: Left SOC / Right Investigational, Split-Scalp: Left Investigational / Right SOC, Split-Scalp: Left SOC / Right Investigational |
Primary outcome
Number of Actinic Keratoses; Baseline
Time frame: Baseline
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Number of Actinic Keratoses; Day 8
Time frame: Day 8
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Number of Actinic Keratoses; Day 56
Time frame: Day 56
Total numerical counts of actinic keratoses (AKs) assessed and documented.
6 secondary outcomes
Skin redness at treatment site(s); Day 8
Time frame: Day 8
Skin redness at treatment site(s); Day 56
Time frame: Day 56
Skin itchiness at treatment site(s); Day 8
Time frame: Day 8
Skin itchiness at treatment site(s); Day 56
Time frame: Day 56
Pain at treatment site(s); Day 8
Time frame: Day 8
Pain at treatment site(s); Day 56
Time frame: Day 56
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna Kolodney, MD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 5% 5-fluorouracil (5-FU) powder and 5% 5-fluorouracil (5-FU) powder PLUS 15% Aluminum Chloride Hexahydrate (ACH) in people with Actinic Keratoses, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vlad Codrea, MD, PhD (304-598-4548, vlad.codrea@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Actinic Keratoses; Baseline (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.