Actinic Keratosis Clinical Trial
Official title:
Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.
The objective of this study is to determine the efficacy, safety, and patient satisfaction of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate photodynamic therapy (MAL PDT). Patients diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol mebutate (Picato®) and photodynamic therapy will act both as the test group and the control group. Each patient will have four distinct treatment areas of 25cm2 on the scalp, and/or scalp and face. Three of the treatment areas will receive Picato® 0.015% gel, MAL PDT, or Picato® 0.015% and MAL PDT combined. One area will serve as a control and will receive none of the treatments.
Study Objective The objective of this study is to determine the efficacy, safety and patient
satisfaction of pretreatment with Picato® gel 4 days prior to methyl aminolevulinate
photodynamic therapy (MAL PDT). This test area will be compared to Picato® treatment alone or
MAL PDT alone treatment areas as well as a control field (no treatment).
Rationale This study focuses on the topical treatment of actinic keratosis. Patients
diagnosed with actinic keratosis who are eligible to receive topical treatment with ingenol
mebutate (Picato®) and photodynamic therapy will act both as the test group and the control
group. Patients will be followed through appointments with the study nurse and dermatologist.
Patient treatment eligibility and regimen for prescribed medication are at Dr. Rivers (and
patient's) discretion. Patients will be followed in the study for the duration of one
complete treatment plus 2 months.
Study duration:
The inclusion period is 6 months, depending on the speed of patient recruitment. The study
duration for each individual patient will end eight weeks after treatment completion.
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