Randomized, Multi-Center, Evaluator-Blind, Vehicle-Controlled Study to Evaluate Efficacy and Safety of Reformulated Levulan Kerastick Plus Photodynamic Therapy (PDT) for Field-Directed Treatment in Patients With Actinic Keratosis (AK) of Face and (Bald) Scalp

Summary

This Phase 3, randomized, multi-center, evaluator-blind, vehicle-controlled study evaluates the efficacy and safety of reformulated Levulan Kerastick (aminolevulinic acid HCl 20%) combined with photodynamic therapy (PDT) for field-directed treatment of actinic keratosis (AK) on the face or bald scalp. Approximately 160 adult patients with 4-8 mild to moderate AK lesions will be randomized into four treatment arms based on two variables: type of treatment (active drug or vehicle) and incubation time. During the study, up to 2 PDT sessions may be administered depending on the clearance of lesions. The primary endpoint is complete clearance rate (CCR) at Week 12. Secondary endpoints include AK clearance rate (AKCR), partial clearance, change in total lesion count and area, recurrence rate, cosmetic response, and patient satisfaction. Safety assessments include adverse events, local skin reactions, vital signs, and lab tests.

Eligibility

Age range

18–85 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Reformulated Levulan Kerastick containing aminolevulinic acid hydrochloride (ALA HCl), 20%

  Solution for topical use

• Other
  Vehicle containing excipients only (VEH) without active ingredient

  Solution for topical use

• Device
  Blue Light Photodynamic Therapy Illuminator device, BLU-U® model 4170E

  BLU-U® blue light Photodynamic Therapy (PDT) illuminator

Locations (10)