Expired Study
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Sacramento, California 95816


Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

553703


NCT ID:

NCT02594644


Secondary ID:


Study Acronym:


Brief Title:

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy


Official Title:

The Use of Microneedles to Expedite Treatment Time in Photodynamic Therapy


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, Davis


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

32


Enrollment Type:

Actual


Overall Contact Information

Official Name:Raja Sivamani, M.D.
Principal Investigator
University of California, Davis

Study Dates

Start Date:November 6, 2014
Completion Date:June 22, 2016
Completion Type:Actual
Primary Completion Date:June 22, 2016
Primary Completion Type:Actual
Verification Date:October 2018
Last Changed Date:October 30, 2018
First Received Date:October 31, 2015
First Results Date:November 3, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Visual Analog Pain Scale
Time Frame:Immediately Post-Treatment
Safety Issues:False
Description: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 betw
Outcome Type:Primary Outcome
Measure:Difference in the Percentage of Complete Clearance of the Actinic Keratoses
Time Frame:Baseline, 2 Months
Safety Issues:False
Description: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.

Study Interventions

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

Study Arms

Study Arm Type:Experimental
Arm Name:20-minute Incubation with Microneedle Roller & Sham
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.
Study Arm Type:Experimental
Arm Name:10-minute Incubation with Microneedle Roller & Sham
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, Davis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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