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

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ClinicalTrials.gov Identifier: NCT00814528
Recruitment Status : Terminated (Not enough subjects for study to be completed.)
First Posted : December 25, 2008
Last Update Posted : March 26, 2014
Information provided by (Responsible Party):
University of Chicago

Brief 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).

Condition or disease Intervention/treatment
Actinic Keratosis Drug: 5-ALA plus Blu-Light Drug: 5-FU, Imiquimod or treatment with cryotherapy

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
Study Start Date : November 2007
Primary Completion Date : September 2009
Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1
Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).
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.
Experimental: 2
5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.
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.

Primary Outcome Measures :
  1. Actinic keratosis /incomplete therapy and reoccurence [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Erythema [ Time Frame: 2 weeks post therapy ]
    Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 18-95 years old
  • Diagnosied with actinic keratoses.

Exclusion Criteria:

  • Patients who have had Isotretinoin therapy less that 1 year prior to screening.
  • Patients who have an adverse reaction to light exposure (for example photo- exacerbated seizures).
  • History of porphyria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00814528

United States, Illinois
The University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Principal Investigator: Maria Tsoukas, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00814528     History of Changes
Other Study ID Numbers: 15725A
First Posted: December 25, 2008    Key Record Dates
Last Update Posted: March 26, 2014
Last Verified: March 2014

Keywords provided by University of Chicago:
actinic keratosis
skin lesions

Additional relevant MeSH terms:
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Aminolevulinic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers
Photosensitizing Agents
Dermatologic Agents