Indoor Daylight Photo Dynamic Therapy for Actinic Keratosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand better if indoor daylight Photo Dynamic Therapy (PDT) can provide effective lesion clearing versus conventional red lamp light therapy.

Detailed Description
-----------------
Subjects who enroll into this research study, their participation in this study will last up to 6 months. They will be asked to return to the clinic 3-4 times. Subjects will be randomized into one of two study arms: Arm 1 - Indoor Daylight PDT Therapy Arm 2 - FDA Approved Standard Light Therapy Treatment

Official Title
-----------------
Indoor Daylight Photo Dynamic Therapy (PDT) for Actinic Keratosis

Conditions
-----------------
Actinic Keratosis

Intervention / Treatment
-----------------
* Other: Amulez and sunlight
* Other: Amulez and red light treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with actinic keratosis appearing at the Dermatology Clinic for PDT treatment. Age ≥ 18 years older. Exclusion Criteria: Pregnant women or women who are breast-feeding. Any patients with a condition that makes them not suitable for clinical PDT.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indoor Daylight PDT Therapy<br>Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will be exposed to natural sunlight through a window for 2 hours. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods. | Other: Amulez and sunlight<br>* Amulez and sun exposure for 2 hours<br>|
| Active Comparator: FDA Approved Standard Light Therapy Treatment<br>Ameluz will be applied to skin. This will be followed by a 30-minute incubation period. Subsequently, you will receive Red Light Treatment for 10 minutes. Post-treatment assessments will be performed and you will be given instruction on appropriate sun protection methods. | Other: Amulez and red light treatment<br>* Amulez and red light treatment for 10 minutes<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes or clearing of the lesions | The primary aim of this study is to study if indoor daylight PDT can be as effective as regular lamp light PDT. This study can be confounded by the amount of PpIX produced in the lesions as well as the clearing of lesions at one month and six months. | Baseline, immediately post-procedure (2 hours) and one and 6 months | 
| Change in the amount of PpIX in the lesion | Secondary diagnostic study to determine if low-cost cellphone-based skin dosimetry in PDT can facilitate objective measurement of drug levels. | Baseline and immediately post procedure |