Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
Not Applicable
Withdrawn
- Conditions
- Actinic Keratosis
- Interventions
- Drug: 5-ALA plus Blu-LightDrug: 5-FU, Imiquimod or treatment with cryotherapy
- Registration Number
- NCT00814528
- Lead Sponsor
- University of Chicago
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- 18-95 years old
- Diagnosied with actinic keratoses.
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 5-ALA plus Blu-Light Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm). 2 5-FU, Imiquimod or treatment with cryotherapy 5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.
- Primary Outcome Measures
Name Time Method Actinic keratosis /incomplete therapy and reoccurence 18 months
- Secondary Outcome Measures
Name Time Method Erythema 2 weeks post therapy Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
Trial Locations
- Locations (1)
The University of Chicago
🇺🇸Chicago, Illinois, United States