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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 8 |
| Skin redness at treatment site(s); Day 56 |
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Inclusion Criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vlad Codrea, MD, PhD | Contact | 304-598-4548 | vlad.codrea@hsc.wvu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joanna Kolodney, MD | West Virginia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Virginia University | Recruiting | Morgantown | West Virginia | 26505 | United States |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D011208 | Powders |
| D000077410 | Aluminum Chloride |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Containers labeled A or B; identity of SOC 5% 5-FU vs investigational 5% 5-FU + 15% ACH concealed from participants and investigators.
| 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. |
|
| 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. |
|
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. |
| 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. | 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. | 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. | 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. | Day 56 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D017607 | Aluminum Compounds |
| D007287 | Inorganic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |