The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Not Applicable

Completed

Conditions: Keratosis, Actinic

Interventions: Device: Microneedle Roller
Drug: Aminolevulinic Acid
Radiation: Blue Light

Registration Number: NCT02594644

Lead Sponsor: University of California, Davis

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 32

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10-minute Incubation with Microneedle Roller & Sham	Microneedle Roller	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.
20-minute Incubation with Microneedle Roller & Sham	Microneedle Roller	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.
10-minute Incubation with Microneedle Roller & Sham	Blue Light	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.
20-minute Incubation with Microneedle Roller & Sham	Blue Light	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.
10-minute Incubation with Microneedle Roller & Sham	Aminolevulinic Acid	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.
20-minute Incubation with Microneedle Roller & Sham	Aminolevulinic Acid	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.

Primary Outcome Measures

Name	Time	Method
Difference in the Percentage of Complete Clearance of the Actinic Keratoses	Baseline, 2 Months	The primary endpoint will be the difference in the percentage of complete clearance of the actinic keratoses as an intraindividual comparison between the treatment groups.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Pain Scale	Immediately Post-Treatment	The secondary will be any pain associated with the microneedle pretreatment and with the application of the PDT using the 100 mm Visual Analog Scale pain grading. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.