The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

University of California (UC) Davis

Status: Completed

Conditions: Keratosis, Actinic

Treatments: Radiation: Blue Light; Device: Microneedle Roller; Drug: Aminolevulinic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02594644

553703

Details and patient eligibility

About

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Full description

The current standard of care of photodynamic therapy to treat actinic keratoses includes pre-treatment of the area with topical aminolevulinic acid for 1 hour, followed by treatment with blue light. In a previous study, the investigators showed pretreatment of microneedles enhance penetration of topical aminolevulinic acid as compared to the control group.

The aim of this study is to investigate how varying incubation periods of topical aminolevulinic acid after pretreatment with microneedle application can facilitate the penetration and efficacy of photodynamic therapy.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age and older
• Subjects has actinic keratoses and qualifies for photodynamic therapy
• Do not meet any of the exclusion criteria

Exclusion criteria

• Subjects who smoke
• Subjects who have a photosensitizing condition such as lupus, porphyria, or similar condition
• Subjects who have established allergy to topical ALA
• Subjects who have had a documented nonmelanoma skin cancer on the face over the past 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

10-minute Incubation with Microneedle Roller & Sham

Experimental group

Description:

10-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Treatment:

Radiation: Blue Light

Drug: Aminolevulinic Acid

Device: Microneedle Roller

20-minute Incubation with Microneedle Roller & Sham

Experimental group

Description:

20-minute topical aminolevulinic acid incubation group. Subjects randomized by binary randomization into each treatment group and undergo secondary binary randomization for microneedle roller treatment (vs. sham microneedle) to the right or left side of the face. Blue light therapy follows.

Treatment:

Radiation: Blue Light

Drug: Aminolevulinic Acid

Device: Microneedle Roller