Phase 3 Study of Reformulated Levulan Kerastick with Photodynamic Therapy for Treating Actinic Keratosis on the Face or Bald Scalp

What this Trial Is About

Researchers are evaluating the efficacy and safety of reformulated Levulan Kerastick aminolevulinic acid HCl 20% combined with photodynamic therapy PDT for treating actinic keratosis AK lesions on the face or bald scalp. This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study involves about 160 adult patients having 4 to 8 mild to moderate AK lesions. The study aims to compare different treatment approaches and incubation times to understand their effects on AK clearance and patient satisfaction. Participants will be assigned to one of four groups based on treatment typeeither the active drug Levulan or a vehicle without active ingredientand one of two incubation times before blue light therapy is applied. Up to two PDT sessions may be given depending on how the lesions respond. The study includes both drug and device interventions, specifically topical solutions and a blue light PDT device. During the study, participants will undergo multiple assessments including evaluations of lesion clearance, changes in lesion count and size, cosmetic response, and patient satisfaction at various time points up to 24 weeks. Safety will be monitored through adverse event reporting, skin reaction assessments, vital signs, and laboratory tests. The main outcome measure is the complete clearance rate of AK lesions at 12 weeks. Participants will be followed closely to assess treatment effects and safety over the study period.

Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp