The Use of Microneedles in Photodynamic Therapy

University of California (UC) Davis

Status: Completed

Conditions: Actinic Keratosis

Treatments: Radiation: Blue light; Device: Microneedle; Drug: Aminolevulinic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT01812837

282150

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 4 patient groups

20 minutes incubation - with pretreatment

Experimental group

Treatment:

Device: Microneedle

Radiation: Blue light

Drug: Aminolevulinic Acid

40 minutes incubation - with pretreatment

Experimental group

Treatment:

Device: Microneedle

Radiation: Blue light

Drug: Aminolevulinic Acid

60 minutes incubation - with pretreatment

Experimental group

Treatment:

Device: Microneedle

Radiation: Blue light

Drug: Aminolevulinic Acid

60 minutes incubation - no pretreatment

Sham Comparator group

Treatment:

Radiation: Blue light

Drug: Aminolevulinic Acid