Levulan Kerastick + PDT for Actinic Keratosis

This trial tests a new version of Levulan Kerastick (a topical solution) combined with photodynamic therapy (PDT) to treat actinic keratosis (AK), which are rough, scaly patches caused by sun exposure on the face or scalp. Researchers aim to determine if this treatment can completely clear AK lesions and improve skin appearance compared to a placebo. Suitable candidates for this trial are adults with 4-8 mild to moderate AK spots on their face or bald scalp and who are in good general health. Participants will be randomly assigned to different groups, receiving either the active treatment or a placebo, with varying incubation times before light therapy. 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 stopping certain topical and systemic medications before participating. You must stop using specific topical treatments on the treatment area 2 days to 8 weeks before starting, and certain systemic medications 6 weeks to 6 months before. Check with the trial team to see if your current medications are affected.

Previous studies have shown that using Levulan Kerastick with photodynamic therapy (PDT) effectively and safely treats actinic keratosis (AK), which are rough, scaly skin patches. Research indicates that most patients tolerate the treatment well, with temporary pain during the procedure as the main side effect. Other studies found that side effects typically resolve after treatment ends. This treatment is also recommended for managing AK because it improves the skin's appearance.¹²³⁴⁵

Researchers are excited about the reformulated Levulan Kerastick for treating actinic keratosis because it employs a unique photodynamic therapy (PDT) approach. Unlike traditional treatments like cryotherapy and topical creams, this method uses a blue light application after the Levulan is applied to the skin. This combination targets precancerous cells more precisely, potentially leading to fewer side effects and faster recovery. The reformulated Levulan allows for varied incubation times, offering flexibility and potentially enhancing effectiveness compared to existing options.

This trial will evaluate the effectiveness of Reformulated Levulan Kerastick with blue light therapy for treating actinic keratosis (AK), which are rough, scaly patches on the skin. Studies have shown that Levulan Kerastick with blue light therapy can clear up to 100% of AK spots without causing scars or changes in skin color. The treatment is non-invasive, as it doesn't involve cutting the skin, and patients usually see good cosmetic results. Previous results also show that spots can completely disappear after treatment. The FDA has approved this method, highlighting its effectiveness for mild to moderate AK. Participants in this trial will receive either the Levulan application with different incubation times or a vehicle application as a placebo comparator.¹²³⁶⁷