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Microneedle Lesion Preparation Prior to Aminolevulinic Acid Photodynamic Therapy (ALA-PDT) for AK on Face

NCT02632110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2018-01-18

Study results available
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Summary

The purpose of this study is to determine the viability of microneedle lesion preparation (MN) to enhance treatment benefit when performed prior to ALA PDT to an actinic keratosis (AK) field on the face.

Conditions

  • Actinic Keratosis

Interventions

DRUG

ALA

20% ALA applied to face prior to light treatment

DRUG

Topical Solution Vehicle

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment

DEVICE

IBL 10 mW

10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds

PROCEDURE

Microneedle lesion preparation

Microneedling of all visible/palpable AK lesions prior to solution application.

DEVICE

IBL 20 mW

10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart Marcus, MD, PhD · DUSA Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2016-09-12
Completion
2016-09-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02632110 on ClinicalTrials.gov