- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00558688
A Photodynamic Therapy for Treatment of Actinic Keratoses
December 2, 2021 updated by: Murad Alam, Northwestern University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Northwestern University Department of Dermatology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
Light Therapy
|
Photodynamic therapy applied to actinic keratoses
|
Experimental: 2
Light Therapy
|
Photodynamic therapy applied to actinic keratoses
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Visual assessment of lesions
Time Frame: 4 weeks
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient subjective assessment and Safety
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
November 13, 2007
First Submitted That Met QC Criteria
November 13, 2007
First Posted (Estimate)
November 15, 2007
Study Record Updates
Last Update Posted (Actual)
December 6, 2021
Last Update Submitted That Met QC Criteria
December 2, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00000312
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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