Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses
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|ClinicalTrials.gov Identifier: NCT00814528|
Recruitment Status : Withdrawn (The study never started due to the Principal Investigator leaving the institution)
First Posted : December 25, 2008
Last Update Posted : September 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Actinic Keratosis||Drug: 5-ALA plus Blu-Light Drug: 5-FU, Imiquimod or treatment with cryotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||September 2009|
|Actual Study Completion Date :||September 2009|
Application of 5-ALA PDT to some lesions on skin with "Blue U" light source (417 nm).
Drug: 5-ALA plus Blu-Light
20% 5-ALA ampoules will be crushed and prepared for application after shaking for 3 minutes. Topical ALA will be applied liberally on skin with extra pressure on lesions. Incubation of ALA will take place for 0-3 hours. Exposure to Blue U light source (417 nm) (DUSA), will be performed for Actinic Keratosis for 15 minutes. Application of combination light sources will be performed when lesions are traced with one pass of Pulsed dye laser (595 nm) (Candela) followed by exposure to Blue U light source for 5-8 minutes pending response.
5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin.
Drug: 5-FU, Imiquimod or treatment with cryotherapy
Cryotherapy will be performed on lesions only every 2 week intervals. Application of Imiquimod will be done on the treated skin area 5 days weekly for 4-6 weeks. 5-FU will be once daily on the treated areas 4- 6 weeks. Responses will be monitored every 2 weeks.
- Actinic keratosis /incomplete therapy and reoccurence [ Time Frame: 18 months ]
- Erythema [ Time Frame: 2 weeks post therapy ]Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation)
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): NCT00814528
|United States, Illinois|
|The University of Chicago|
|Chicago, Illinois, United States, 60637|
|Principal Investigator:||Maria Tsoukas, MD||University of Chicago|