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

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ClinicalTrials.gov Identifier: NCT02354391
Recruitment Status : Unknown
Verified March 2019 by Jason K Rivers, MD, FRCPC, FAAD, Pacific Dermaesthetics.
Recruitment status was:  Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
LEO Pharma
Information provided by (Responsible Party):
Jason K Rivers, MD, FRCPC, FAAD, Pacific Dermaesthetics

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.

Condition or disease Intervention/treatment Phase
Actinic Keratosis Drug: Ingenol mebutate Picato® and MAL PDT day 1, day 5 Drug: Ingenol mebutate Picato® day 2, 3, 4 Procedure: MAL PDT day 5 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.
Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.
Drug: Ingenol mebutate Picato® and MAL PDT day 1, day 5
Treatment of ingenol mebutate, Picato® 0.015% topical gel applied on day 1 followed by MAL PDT on day 5
Other Name: Picato® 0.015% and MAL PDT

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

Procedure: MAL PDT day 5
Methyl aminolevulate combined with Photodynamic therapy at day 5
Other Name: MAL PDT




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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).

  11. 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).

  12. 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).

  13. 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:

    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)



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Jason K Rivers, MD, FRCPC, FAAD, Principal Investigator, Pacific Dermaesthetics
ClinicalTrials.gov Identifier: NCT02354391    
Other Study ID Numbers: 1969699
First Posted: February 3, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Additional relevant MeSH terms:
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Keratosis, Actinic
Keratosis
Skin Diseases
Precancerous Conditions
Neoplasms