Clinical trial NCT02354391: Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis
Official title: Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Actinic Keratosis
Lead sponsor: Pacific Dermaesthetics
Sponsor class: OTHER
Collaborators: name: LEO Pharma
First posted: 2015-02-03
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Age \> 40 yrs
2. Patients eligible to receive topical treatment with ingenol mebutate gel and photodynamic therapy for treatment of actinic keratosis at the discretion of the dermatologist.
3. Fitzpatrick Skin Type I \& II.
4. Patient must give informed consent.

Exclusion Criteria:

1. Diagnosis of Basal Cell Carcinoma(BCC), Squamous Cell Carcinoma(SCC) or melanoma in the treatment area.
2. Currently experiencing adverse reactions and/or Local Skin Reactions from previous Actinic Keratosis(AK) treatment in the treatment field.
3. Females who are pregnant, nursing or planning a pregnancy during their participation in the study.
4. Female subjects of childbearing potential (including subjects using surgical sterilization, ie, bilateral tubal ligation or implanted device methods of contraception) with a positive urine pregnancy test at Day 1 prior to study treatment; a female is considered NOT to be of childbearing potential if she is post-menopausal with at least 12 consecutive months of amenorrhea, has undergone bilateral oophorectomy, or has no uterus.

Primary outcomes:
measure: Complete clearance of lesions
timeFrame: 60 days
Secondary outcomes:
measure: Localized skin response to Erythema is measured using a 4 point scale, 0 (no erythema) to 3 (severe erythema)
timeFrame: Day 5, 8 and 15
measure: Count of actinic kertosis lesions
timeFrame: 60 days (day 15, 30 and 60)
measure: Localized skin response to Flaking/Scaling is measured using a 4 point scale, 0 (no flaking/scaling) to 3 (severe flaking/scaling)
timeFrame: Day 5, 8 and 15
measure: Localized skin response to Pustulation is measured using a 4 point scale, 0 (no pustulation) to 3 (severe pustulation)
timeFrame: Day 5, 8 and 15
measure: Localized skin response to Vesiculation is measured using a 4 point scale, 0 (no vesiculation) to 3 (severe vesiculation)
timeFrame: Day 5, 8 and 15
measure: Localized skin response to Pain is measured using a 4 point scale, 0 (no pain) to 3 (severe pain)
timeFrame: Day 5, 8 and 15
measure: Localized skin response to Crusting is measured using a 4 point scale, 0 (no crusting) to 3 (severe crusting)
timeFrame: Day 5, 8 and 15
measure: Localized skin response to Swelling is measured using a 4 point scale, 0 (no swelling) to 3 (severe swelling)
timeFrame: Day 5, 8 and 15
measure: Localized skin response to Erosion/Ulceration is measured using a 4 point scale, 0 (no erosion/ulceration) to 3 (severe erosion/ulceration)
timeFrame: Day 5, 8 and 15
measure: VAS questionnaire - How much pain was associated with the use of Picato® for 3 days?
timeFrame: Day 5
measure: VAS questionnaire - How much pain was associated with the use of Picato® followed by PDT?
timeFrame: Day 5
measure: VAS questionnaire - How much pain did you experience in the PDT treatment area?
timeFrame: Day 5
measure: Patient Assessment Questionnaire - Patient evaluation of the following treatments: Ingenol mebutate 0.015% topical gel, MAL PDT, and Ingenol mebutate 0.05% topical gel combined with MAL PDT.
timeFrame: Day 15
Other outcomes:
Locations:
Study officials:
References: