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ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients

NCT00865878 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2011-10-21

No results posted yet for this study

Summary

The purpose of this study is to determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the treatment of actinic keratoses (AK) and reduction of new non-melanoma skin cancer (NMSC) of the scalp or both forearms in solid organ transplant recipient subjects receiving chronic immunosuppressive therapy.

Conditions

  • Actinic Keratoses
  • Skin Neoplasms

Interventions

DRUG

Aminolevulinic Acid

20% aminolevulinic acid HCL (ALA) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) ALA-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.

OTHER

Vehicle

Vehicle ingredients only (VEH) applied topically for 90 +/- 30 minutes prior to treatment with 10 j/cm2 blue light. Up to nine (9) VEH-PDT treatments will be given: The initial four (4) treatments will be given at 4-5 week intervals, with the remaining five (5) treatments given every 6 +/-1 weeks.

Sponsors & Collaborators

  • DUSA Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Stuart L Marcus, MD, PhD · Sponsor GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2011-09-30
Completion
2011-09-30

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 NCT00865878 on ClinicalTrials.gov