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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
32
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.
West Virginia University
Morgantown, West Virginia, United States
RECRUITINGNumber of Actinic Keratoses; Baseline
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Time frame: Baseline
Number of Actinic Keratoses; Day 8
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Time frame: Day 8
Number of Actinic Keratoses; Day 56
Total numerical counts of actinic keratoses (AKs) assessed and documented.
Time frame: Day 56
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 56
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