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

This study has been terminated.
(Not enough subjects for study to be completed.)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00814528
First received: December 23, 2008
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Actinic keratosis /incomplete therapy and reoccurence [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Erythema [ Time Frame: 2 weeks post therapy ] [ Designated as safety issue: No ]
    Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)


Enrollment: 3
Study Start Date: November 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814528

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

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00814528     History of Changes
Other Study ID Numbers: 15725A
Study First Received: December 23, 2008
Last Updated: March 24, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
actinic keratosis
skin lesions
5-ALA
AK
Blu-Light

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Ichthyosis
Keratoacanthoma
Skin Diseases
Precancerous Conditions
Neoplasms
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Aminolevulinic Acid
Imiquimod
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors
Antineoplastic Agents
Interferon Inducers

ClinicalTrials.gov processed this record on April 17, 2014