Overview

This trial is active, not recruiting.

Condition actinic keratosis
Treatments ingenol mebutate picato® and mal pdt day 1, day 5, ingenol mebutate picato® day 2, 3, 4, mal pdt day 5
Phase phase 2
Sponsor Pacific Dermaesthetics
Collaborator LEO Pharma
Start date January 2015
End date September 2016
Trial size 20 participants
Trial identifier NCT02354391, 1969699

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
ingenol mebutate picato® and mal pdt day 1, day 5 Picato® 0.015% and MAL PDT
Treatment of ingenol mebutate, Picato® 0.015% topical gel applied on day 1 followed by MAL PDT on day 5
ingenol mebutate picato® day 2, 3, 4 Picato® 0.015%
Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4
mal pdt day 5 MAL PDT
Methyl aminolevulate combined with Photodynamic therapy at day 5

Primary Outcomes

Measure
Complete clearance of lesions
time frame: 60 days

Secondary Outcomes

Measure
Localized skin response to Erythema is measured using a 4 point scale, 0 (no erythema) to 3 (severe erythema)
time frame: Day 5, 8 and 15
Count of actinic kertosis lesions
time frame: 60 days (day 15, 30 and 60)
Localized skin response to Flaking/Scaling is measured using a 4 point scale, 0 (no flaking/scaling) to 3 (severe flaking/scaling)
time frame: Day 5, 8 and 15
Localized skin response to Pustulation is measured using a 4 point scale, 0 (no pustulation) to 3 (severe pustulation)
time frame: Day 5, 8 and 15
Localized skin response to Vesiculation is measured using a 4 point scale, 0 (no vesiculation) to 3 (severe vesiculation)
time frame: Day 5, 8 and 15
Localized skin response to Pain is measured using a 4 point scale, 0 (no pain) to 3 (severe pain)
time frame: Day 5, 8 and 15
Localized skin response to Crusting is measured using a 4 point scale, 0 (no crusting) to 3 (severe crusting)
time frame: Day 5, 8 and 15
Localized skin response to Swelling is measured using a 4 point scale, 0 (no swelling) to 3 (severe swelling)
time frame: Day 5, 8 and 15
Localized skin response to Erosion/Ulceration is measured using a 4 point scale, 0 (no erosion/ulceration) to 3 (severe erosion/ulceration)
time frame: Day 5, 8 and 15
VAS questionnaire - How much pain was associated with the use of Picato® for 3 days?
time frame: Day 5
VAS questionnaire - How much pain was associated with the use of Picato® followed by PDT?
time frame: Day 5
VAS questionnaire - How much pain did you experience in the PDT treatment area?
time frame: Day 5
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.
time frame: Day 15

Eligibility Criteria

Male or female participants at least 40 years old.

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.

Additional Information

Official title Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Pacific Dermaesthetics.