- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02354391
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.
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age > 40 yrs
- Patients eligible to receive topical treatment with ingenol mebutate gel and photodynamic therapy for treatment of actinic keratosis at the discretion of the dermatologist.
- Fitzpatrick Skin Type I & II.
- Patient must give informed consent.
Exclusion Criteria:
- Diagnosis of Basal Cell Carcinoma(BCC), Squamous Cell Carcinoma(SCC) or melanoma in the treatment area.
- Currently experiencing adverse reactions and/or Local Skin Reactions from previous Actinic Keratosis(AK) treatment in the treatment field.
- Females who are pregnant, nursing or planning a pregnancy during their participation in the study.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ingenol mebutate and MAL PDT
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
Other Names:
Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4
Other Names:
Methyl aminolevulate combined with Photodynamic therapy at day 5
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete clearance of lesions
Time Frame: 60 days
|
The proportion of patients with complete clearance of actinic keratoses in the treatment area compared to baseline.
|
60 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
Day 5, 8 and 15
|
Count of actinic kertosis lesions
Time Frame: 60 days (day 15, 30 and 60)
|
The percent change in actinic keratosis count as compared to the baseline lesion count.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
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
|
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.
|
Day 5, 8 and 15
|
VAS questionnaire - How much pain was associated with the use of Picato® for 3 days?
Time Frame: Day 5
|
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).
|
Day 5
|
VAS questionnaire - How much pain was associated with the use of Picato® followed by PDT?
Time Frame: Day 5
|
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).
|
Day 5
|
VAS questionnaire - How much pain did you experience in the PDT treatment area?
Time Frame: Day 5
|
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).
|
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
|
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:
|
Day 15
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1969699
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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