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Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

NCT00814528 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-09-10

No results posted yet for this study

Summary

The purpose of this study is to compare the treatment of skin growths called actinic keratoses (AK) with 5-ALA PDT, an FDA-approved treatment, versus treatment with other conventionally used FDA-approved agents such as cryotherapy, Imiquimod, or 5-fluorouracil (5-FU).

Conditions

  • Actinic Keratosis

Interventions

DRUG

5-ALA plus Blu-Light

20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.

DRUG

5-FU, Imiquimod or treatment with cryotherapy

Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.

Sponsors & Collaborators

  • University of Chicago

    lead OTHER

Principal Investigators

  • Maria Tsoukas, MD · University of Chicago

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-09-30
Completion
2009-09-30

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 NCT00814528 on ClinicalTrials.gov