Back to resultsA Photodynamic Therapy for Treatment of Actinic Keratoses
Primary Purpose
Actinic Keratoses
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photodynamic therapy
Sponsored by
About this trial
This is an interventional treatment trial for Actinic Keratoses
Eligibility 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
Sites / Locations
- Northwestern University Department of Dermatology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Light Therapy
Light Therapy
Outcomes
Primary Outcome Measures
Visual assessment of lesions
Secondary Outcome Measures
Patient subjective assessment and Safety
Full Information
NCT ID
NCT00558688
First Posted
November 13, 2007
Last Updated
December 2, 2021
Sponsor
Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT00558688
Brief Title
A Photodynamic Therapy for Treatment of Actinic Keratoses
Official Title
A Photodynamic Therapy for Treatment of Actinic Keratoses
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Actinic Keratoses
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Light Therapy
Arm Title
2
Arm Type
Experimental
Arm Description
Light Therapy
Intervention Type
Procedure
Intervention Name(s)
Photodynamic therapy
Intervention Description
Photodynamic therapy applied to actinic keratoses
Primary Outcome Measure Information:
Title
Visual assessment of lesions
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Patient subjective assessment and Safety
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murad Alam, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Photodynamic Therapy for Treatment of Actinic Keratoses
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