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A Photodynamic Therapy for Treatment of Actinic Keratoses

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ClinicalTrials.gov Identifier: NCT00558688
Recruitment Status : Completed
First Posted : November 15, 2007
Last Update Posted : February 20, 2015
Sponsor:
Information provided by (Responsible Party):
Murad Alam, Northwestern University

Brief Summary:
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 or disease Intervention/treatment
Actinic Keratoses Procedure: Photodynamic therapy

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Photodynamic Therapy for Treatment of Actinic Keratoses
Study Start Date : August 2007
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Visual assessment of lesions [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Patient subjective assessment and Safety [ Time Frame: 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

Responsible Party: Murad Alam, Professor in Dermatology, Otolaryngology-Head and Neck Surgery, and Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT00558688     History of Changes
Other Study ID Numbers: STU00000312
First Posted: November 15, 2007    Key Record Dates
Last Update Posted: February 20, 2015
Last Verified: February 2015

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