The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

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.

Study Overview

• Status: Completed
• Conditions: Keratosis, Actinic
• Intervention / Treatment: Drug: Aminolevulinic Acid; Device: Microneedle Roller; Radiation: Blue Light

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • University of California-Davis, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10-minute Incubation with Microneedle Roller & Sham; 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.	Drug: Aminolevulinic Acid; Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA; Device: Microneedle Roller; The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.; Radiation: Blue Light; Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
Experimental: 20-minute Incubation with Microneedle Roller & Sham; 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.	Drug: Aminolevulinic Acid; Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA; Device: Microneedle Roller; The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.; Radiation: Blue Light; Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the Percentage of Complete Clearance of the Actinic Keratoses	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.	Baseline, 2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Scale	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.	Immediately Post-Treatment

Collaborators and Investigators

• Sponsor: University of California, Davis
• Investigators: Principal Investigator: Raja Sivamani, M.D., University of California, Davis

Publications and helpful links

General Publications

• Petukhova TA, Hassoun LA, Foolad N, Barath M, Sivamani RK. Effect of Expedited Microneedle-Assisted Photodynamic Therapy for Field Treatment of Actinic Keratoses: A Randomized Clinical Trial. JAMA Dermatol. 2017 Jul 1;153(7):637-643. doi: 10.1001/jamadermatol.2017.0849.

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2014
• Primary Completion (Actual): June 22, 2016
• Study Completion (Actual): June 22, 2016

Study Registration Dates

• First Submitted: October 31, 2015
• First Submitted That Met QC Criteria: November 2, 2015
• First Posted (Estimate): November 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: October 30, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Precancerous Conditions; Keratosis, Actinic; Keratosis; Photosensitizing Agents; Dermatologic Agents; Aminolevulinic Acid
• Other Study ID Numbers: 553703