Twelve Month Follow-Up of CP0108

Study Overview
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Brief Summary
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The purpose of this study is to determine the long-term safety and efficacy of Levulan PDT in subjects with multiple actinic keratosis of the upper extremities who received treatment as part of the DUSA CP0108 study.

Official Title
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Twelve Month Follow-Up Evaluation of Subjects Participating in DUSA-CP0108 (A Phase 3 Study of Photodynamic Therapy With Levulan Kerastick Topical Solution + Blue Light Versus Topical Solution Vehicle + Blue Light for the Treatment of Actinic Keratoses on the Upper Extremities)

Conditions
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Actinic Keratosis

Intervention / Treatment
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* Drug: Aminolevulinic Acid (ALA)
* Drug: Topical Solution Vehicle
* Device: BLU-U Blue Light Photodynamic Therapy Illuminator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have been enrolled in the DUSA-CP0108 study, completed their assigned treatment and Visit 6 (Week 12).

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALA<br>Subjects who received ALA in CP0108 | Drug: Aminolevulinic Acid (ALA)<br>* Levulan PDT given in CP0108<br>* Other names: Levulan Kerastick;Device: BLU-U Blue Light Photodynamic Therapy Illuminator<br>* PDT given in CP0108<br>|
| Vehicle<br>Subjects who received Vehicle in CP0108 | Drug: Topical Solution Vehicle<br>* Vehicle PDT given in CP0108<br>Device: BLU-U Blue Light Photodynamic Therapy Illuminator<br>* PDT given in CP0108<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Recurrence Rate | percentage of subjects who had achieved 100% clearance at Visit 6 (Week 12) in CP0108, that have one or more previously treated (as part of CP0108) AK lesion(s) present in the Treatment Area at any visit during CP0108A follow-up | Month 12 | 
| Duration of Response | the time from Week 12 (in the DUSA-CP0108 study) to the visit at which a previously treated and cleared lesion recurs. If a subject begins or receives treatment for previously cleared AK lesions in the Treatment Area between scheduled visits, the date the treatment started will be the end of treatment response, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response. | one year | 
| Lesion Recurrence Rate | the proportion of lesions that were CR at Week 12 in CP0108 that are visible or palpable at Visit 10, will be determined for all ALA-PDT treated subjects who have at least one AK designated as clear at Week 12 in the DUSA-CP0108 study. | Month 12 | 
| Duration of Lesion Response | the time from Week 12 (in the DUSA-CP0108 study) to the visit at which the AK lesion recurs for all ALA-PDT treated subjects who have at least one AK designated as clear at Week 12 in the DUSA-CP0108 study. If a previously cleared lesion receives treatment between scheduled visits, the date the treatment started will be the end of treatment response for that lesion, or, if the start date is unknown, the visit prior to starting the new treatment will be the end of treatment response. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Actinic Keratosis