A Photodynamic Therapy for Treatment of Actinic Keratoses

This study has been completed.
Sponsor:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00558688
First received: November 13, 2007
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

The purpose of this study is to compare the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs absence of treatment for actinic keratoses.


Condition Intervention
Actinic Keratoses
Procedure: Photodynamic therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Photodynamic Therapy for Treatment of Actinic Keratoses

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Visual assessment of lesions [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient subjective assessment and Safety [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: August 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Light Therapy
Procedure: Photodynamic therapy
Photodynamic therapy applied to actinic keratoses
Experimental: 2
Light Therapy
Procedure: Photodynamic therapy
Photodynamic therapy applied to actinic keratoses

Detailed Description:

This study seeks to evaluate the efficacy of photodynamic therapy with 5-aminolevulinic acid and intense pulsed light vs. absence of treatment for actinic keratoses

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Age greater than or equal to 18 years

  • Have a t least 4 nonhypertrophic AK lesions on the body
  • The subjects are in good health
  • The subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate to the investigator

Exclusion Criteria:

  • Subjects who are pregnant or lactating
  • Subjects with a history of cutaneous photosensitivity or porphyria, hypersensitivity to porphyrins, or photodermatosis
  • Subjects with use of photosensitizing drugs within 1 week of study start
  • Subjects with use of topical medications such as corticosteroids, alpha-hydroxyacids or retinoids 2 weeks before study entry
  • Subjects with systemic steroid therapy within 4 weeks before study entry
  • Subjects who received previous treatment of target AKs
  • Subjects with systemic treatment with chemotherapeutic agents, masoprocol (Actinex), immunotherapy, or retinoids within 2 months of study entry
  • Subjects with prior history of hypersensitivity reactions to lidocaine
  • Subjects who are unable to understand the protocol or to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00558688

Locations
United States, Illinois
Northwestern University Department of Dermatology
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Murad Alam, MD Northwestern University
  More Information

No publications provided

Responsible Party: Murad Alam, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00558688     History of Changes
Other Study ID Numbers: STU00000312
Study First Received: November 13, 2007
Last Updated: May 25, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Keratosis
Keratosis, Actinic
Skin Diseases
Precancerous Conditions
Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014