Fluorouracil + Calcipotriene for Actinic Keratosis

This trial examines the effectiveness of two treatments for actinic keratosis, a skin condition with rough, scaly patches caused by excessive sun exposure. Researchers compare the effects of a skin cream called fluorouracil alone to a combination of fluorouracil and another cream, calcipotriene. Suitable candidates for this trial have 4 to 15 actinic keratoses on their head, neck, arm, or hand. Participants must begin treatment within a week of joining the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial requires that you stop using certain medications that could affect skin assessment, such as topical steroids, retinoids, and some oral medications like nicotinamide. If you're using any of these, you may need to stop them before participating.

Research has shown that a combination of fluorouracil and calcipotriene for treating actinic keratosis is generally well-tolerated by most patients. Earlier studies demonstrated that this combination significantly cleared skin lesions. However, about 47% of patients experienced local skin reactions, such as redness or irritation, which are usually mild and temporary.

Fluorouracil alone also has a strong safety record. Studies have found it effective and safe, with a low chance of lesions returning. Some patients might notice skin redness or discomfort, but these effects are usually temporary and part of the treatment process.

Researchers are excited about these treatments for actinic keratosis because they combine fluorouracil (5-FU) with calcipotriene, a vitamin D analog, which is a unique approach. While standard treatments like cryotherapy or using 5-FU alone focus on destroying abnormal cells, this combination therapy may enhance the immune response, potentially leading to more effective clearance of lesions. Additionally, calcipotriene may make the skin more receptive to 5-FU, potentially improving its efficacy. With the potential for better results in a shorter time, this combination could offer a promising alternative to existing therapies.

This trial will compare the effectiveness of two treatment options for actinic keratosis. Participants in one arm will receive a combination of fluorouracil and calcipotriene. Studies have shown this combination effectively treats the skin condition by boosting the body's immune response and targeting abnormal cell growth. In one study, 81% of doctors found this combination more effective than fluorouracil alone, although some noted increased skin reactions. Participants in the other arm will receive fluorouracil by itself, which is also effective. Research shows it can clear up to 87% of lesions when combined with other treatments like light therapy. Both treatment options offer promise for those dealing with actinic keratosis.¹⁴⁶⁷⁸