Study of 5% 5-fluorouracil Cream With or Without 15% Aluminum Chloride Hexahydrate to Treat Actinic Keratoses on Scalp or Forearms in Adults

What this Trial Is About

This research aims to find a new way to treat actinic keratoses, which are rough, scaly skin spots caused by long-term sun exposure. These spots are common in adults under 50 with chronically sun-damaged skin and can sometimes develop into skin cancer if untreated. The study is exploring whether adding aluminum chloride hexahydrate to a standard cream treatment improves the reduction of these skin spots. Participants will apply one of two treatments to their affected skin areas either the standard 5% 5-fluorouracil cream alone or a combination of 5% 5-fluorouracil cream plus 15% aluminum chloride hexahydrate cream. The treatment is applied twice daily for one week on either the scalp or forearms. The study uses a split-area approach where one half receives the investigational treatment and the other half receives standard care, with the assignment randomized and blinded. Participants will be examined before treatment, shortly after the one-week treatment ends, and about eight weeks later. During these visits, a dermatologist will count the number of actinic keratoses and take photographs to monitor changes. Researchers will also assess skin redness, itchiness, and pain at the treatment sites. The study will measure how well each treatment reduces the number of skin spots over time and monitor participant safety.

Actinic Keratoses Treated With 5-fluorouracil Plus Aluminum