Actinic Keratoses
Conditions
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.
Interventions
DRUG5% 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.
DRUG5% 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.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
Containers labeled A or B; identity of SOC 5% 5-FU vs investigational 5% 5-FU + 15% ACH concealed from participants and investigators.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Actinic Keratoses; Baseline | Baseline | Total numerical counts of actinic keratoses (AKs) assessed and documented. |
| Number of Actinic Keratoses; Day 8 | Day 8 | Total numerical counts of actinic keratoses (AKs) assessed and documented. |
| Number of Actinic Keratoses; Day 56 | Day 56 | Total numerical counts of actinic keratoses (AKs) assessed and documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin redness at treatment site(s); Day 8 | 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. |
| Skin redness at treatment site(s); Day 56 | 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. |
| Skin itchiness at treatment site(s); Day 8 | 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. |
| Skin itchiness at treatment site(s); Day 56 | 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. |
| Pain at treatment site(s); Day 8 | 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. |
| Pain at treatment site(s); Day 56 | 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. |
Countries
United States
Contacts
CONTACTVlad Codrea, MD, PhD
PRINCIPAL_INVESTIGATORJoanna Kolodney, MD
West Virginia University
Outcome results
None listed