The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Keratosis, Actinic Clinical Trial

Official title:

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594644
• Other study ID #: 553703
• Status: Completed
• Phase: N/A
• Start date: November 6, 2014
• Est. completion date: June 22, 2016

Study information

• Verified date: October 2018
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 22, 2016
• Est. primary completion date: June 22, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratosis
• Keratosis, Actinic

Intervention

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.

Drug:
• Aminolevulinic Acid
Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Radiation:
• Blue Light
Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA

Locations

Country	Name	City	State
United States	University of California-Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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