CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Aminolevulinic Acid +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01812837
NCT01812837N/ACompleted
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The Use of Microneedles in Photodynamic Therapy

University of California, Davis·interventional·Posted Mar 18, 2013·Updated Jun 15, 2017

In Brief

A clinical study evaluating Microneedle, Aminolevulinic Acid, and 1 other intervention for Actinic Keratosis. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The global aim of this study is to investigate how microneedles can facilitate the penetration and efficacy of photodynamic therapy in the treatment of actinic keratoses The specific aims are as follows: 1. Investigate whether pretreatment with microneedles enhances penetration of topical aminolevulinic acid (ALA) that is marketed as Levulan® Kerasticks by DUSA pharmaceuticals Inc. 2. Investigate whether pretreatment with microneedles can decrease the required incubation times of the topical ALA prior to exposure to blue light photodynamic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsActinic Keratosis
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2013
Enrollment StartJul 1, 2012
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.3 years ago

Interventions

Microneedledevice

The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.

Aminolevulinic Aciddrug

Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA

Blue lightradiation

Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)