Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Keratosis, Actinic

Keratosis

Skin Diseases

Precancerous Conditions

Dermatologic Agents

All Drugs and Chemicals

Aminolevulinic Acid

Methyl 5-aminolevulinate

Participants will recieve Ingenol mebutate 0.015% topical gel treatment applied day 2,3 and 4 to quadrant 1. Patients will recieve ingenol mebutate 0.015% applied on day 1 followed by methyl aminolevulate and photodyamnic therapy on day 5 to quadrant 2. Particpants will recieve methyl aminolevulate and photodynamic therapy on day 5 to quadrant 3, and quadrant 4 will act as the control, with no treatment.

Treatment of ingenol mebutate, Picato® 0.015% topical gel applied on day 1 followed by MAL PDT on day 5

Ingenol mebutate Picato® and MAL PDT day 1, day 5

Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4

Ingenol mebutate Picato® day 2, 3, 4

Methyl aminolevulate combined with Photodynamic therapy at day 5

MAL PDT day 5

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.

Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis

Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.

The proportion of patients with complete clearance of actinic keratoses in the treatment area compared to baseline.

Assessment of erythema as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

The percent change in actinic keratosis count as compared to the baseline lesion count.

Assessment of Flaking/Scaling as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Assessment of Pustulation as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Assessment of Vesiculation as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Assessment of Pain as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Assessment of Crusting as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Assessment of Swelling as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Assessment of Erosion/Ulceration as part of an evaluation of tolerance of 3 treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT. This will be done by visual assessment by the Investigator using a 4 point scale. The scale is 0=none present, 1=mild , 2=moderate, and 3=severe.

Participants will be presented with a questionnaire at day 5 asking: How much pain was associated with the use of Picato® for 3 days? Participants will answer using the 0-10 VAS Numeric Pain Distress Scale (0 = no pain, 5 = moderate pain, 10 = unbearable pain).

Participants will be presented with a questionnaire at day 5 asking: How much pain was associated with the use of Picato® followed by PDT? Participants will answer using the 0-10 VAS Numeric Pain Distress Scale (0 = no pain, 5 = moderate pain, 10 = unbearable pain).

Participants will be presented with a questionnaire at day 5 asking:How much pain did you experience in the PDT treatment area? Participants will answer using the 0-10 VAS Numeric Pain Distress Scale (0 = no pain, 5 = moderate pain, 10 = unbearable pain).

Patients will be asked to evaluate each of the treatments they have received (Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT). They will be presented with a questionnaire at Day 15 asking the following questions:

1. Would you used this treatment again? (Yes, No)
2. Talking all things into account, how satisfied or dissatisfied with the outcome of using this medication? (Very dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Extremely Satisfied)
3. How does this treatment compare to the other treatments? (Worse, Slightly Worse, No Change, Slightly Better, Much Better)

Spots Global Cancer Trial Database for ingenol mebutate picato® day 2, 3, 4