Bilateral Comparison of Treatment of Facial Actinic Keratoses Using Microneedling and Photodynamic Therapy With Aminolevulinic Acid and Blue Light Versus Photodynamic Therapy With Aminolevulinic Acid and Blue Light Using Two Incubation Times

• Status: Completed
• Trial end date: 2017-04-13

Summary

This is an investigator initiated, two center, randomized, evaluator-blinded, bilateral (right vs. left) study of photodynamic therapy in subjects with facial actinic keratoses.

Subject's face will be randomized to receive one of four treatments: Treatment 1, Treatment 2, Treatment 3 or Treatment 4. Treatment 1 will include microneedling performed prior to ALA application to their right face and ALA application only to the left face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 2 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 60 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 3 will include microneedling performed prior to ALA application to their right face and ALA application only to the left side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). Treatment 4 will include microneedling performed prior to ALA application to their left face and ALA application only to the right side of their face 30 minutes prior to BLUE light treatment for 1000 seconds (16 minutes 40 seconds). The face is defined as the surface of the skin encompassing the forehead to the hair line and tops of the eyebrows, the entire nasal dorsum, the cheeks (bounded by the orbital rim, the anterior border of the ear, the jawline, the nose and the chin), the upper lip (not including the vermilion border) and the chin (bounded by the lower edge of the vermilion border, the cheek junction and the jawline). The treatment areas will be not be occluded. A line will be drawn with a marker that intersects the nose, forehead, upper lip and chin in the midline. The left face is defined as the face to the left of this line and the right face is defined as the face to the right of this line. Posttreatment follow-up visits will be scheduled to occur 48 hours after the treatment and at 1, 3 and 6 months after the treatment. A blinded evaluator who will remain blinded with respect to the randomization will conduct grading of the subject's actinic keratoses and photodamage. Tolerability of treatment will be assessed by evaluations of the local skin response (erythema, edema, etc.) and will be conducted by an unblinded evaluator.

Safety will be evaluated by adverse events and local skin responses reported during the study

• Phase: Phase 4

Details

• Lead Sponsor: Dermatology, Laser & Vein Specialists of the Carolinas
• Treatments: Aminolevulinic Acid