The Use of Microneedles in Photodynamic Therapy

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses

The specific aims are as follows:

1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc.

2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, Davis
• Treatments: Aminolevulinic Acid

Criteria

Inclusion Criteria:

1. Subjects who are 18 and older

2. Subjects who have at least 3 actinic keratoses on each side of the forehead

3. Subjects who signed an IRB approved informed consent

Exclusion Criteria:

1. Subjects who smoke

2. Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition.

3. Subjects who received a diagnosis of skin cancer on the face in past year

4. Subjects who received field treatment for actinic keratoses to the face in the past 60 days