Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

Study Overview
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Brief Summary
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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).

Official Title
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Photodynamic Therapy Mediated by Topical Application of 5- ALA for the Treatment of Actinic Keratoses

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: 5-ALA plus Blu-Light
* Drug: 5-FU, Imiquimod or treatment with cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-95 years old Diagnosied with actinic keratoses. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Application of 5-ALA PDT to some lesions on skin with Blue U light source (417 nm). | Drug: 5-ALA plus Blu-Light<br>* 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.<br>|
| Experimental: 2<br>5-FU, Imiquimod or treatment with cryotherapy to lesions on the skin. | Drug: 5-FU, Imiquimod or treatment with cryotherapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actinic keratosis /incomplete therapy and reoccurence |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erythema | Early skin responses 2 weeks post therapy (erythema, scaling, post inflammatory skin changes, fine wrinkling of skin, mottled pigmentation) | 2 weeks post therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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actinic keratosis, skin lesions, 5-ALA, AK, Blu-Light