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Levulan PDT Versus Vehicle for Extremity Actinic Keratoses (AK)

NCT01458587 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2013-03-14

Study results available
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Summary

The purpose of this study is to determine if Levulan PDT is safe and effective in the treatment of actinic keratoses on the upper arms and hands.

Conditions

  • Keratosis, Actinic

Interventions

DRUG

Aminolevulinic Acid PDT (ALA)

20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light

DRUG

Vehicle PDT (VEH)

Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light

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
2011-11-30
Primary Completion
2012-07-31
Completion
2012-07-31

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 NCT01458587 on ClinicalTrials.gov