Actinic KeratosisPhase 2NCT02354391
Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis
A Phase 2 study testing Ingenol mebutate Picato® and MAL PDT day 1, day 5, Ingenol mebutate Picato® day 2, 3, 4 and MAL PDT day 5 in people with Actinic Keratosis, run by Pacific Dermaesthetics.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol mebutate Picato® and MAL PDT day 1, day 5, Ingenol mebutate Picato® day 2, 3, 4 and MAL PDT day 5
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.
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.
Read the 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.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate Picato® and MAL PDT day 1, day 5, Ingenol mebutate Picato® day 2, 3, 4, MAL PDT day 5
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol mebutate Picato® and MAL PDT day 1, day 5Drug
Also called 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, 4Drug
Also called Picato® 0.015%
Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4
MAL PDT day 5Procedure or surgery
Also called MAL PDT
Methyl aminolevulate combined with Photodynamic therapy at day 5
| Study group | Role | What they receive |
|---|---|---|
| Ingenol mebutate and MAL PDT | 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. Receives: Drug: Ingenol mebutate Picato® and MAL PDT day 1, day 5; Drug: Ingenol mebutate Picato® day 2, 3, 4; Procedure: MAL PDT day 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance of lesions
The proportion of patients with complete clearance of actinic keratoses in the treatment area compared to baseline.
Measured: 60 days
Secondary outcomes (13)
Localized skin response to Erythema is measured using a 4 point scale, 0 (no erythema) to 3 (severe erythema)
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.
Measured: Day 5, 8 and 15
Count of actinic kertosis lesions
The percent change in actinic keratosis count as compared to the baseline lesion count.
Measured: 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)
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.
Measured: Day 5, 8 and 15
Localized skin response to Pustulation is measured using a 4 point scale, 0 (no pustulation) to 3 (severe pustulation)
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.
Measured: Day 5, 8 and 15
Localized skin response to Vesiculation is measured using a 4 point scale, 0 (no vesiculation) to 3 (severe vesiculation)
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.
Measured: Day 5, 8 and 15
Localized skin response to Pain is measured using a 4 point scale, 0 (no pain) to 3 (severe pain)
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.
Measured: Day 5, 8 and 15
Localized skin response to Crusting is measured using a 4 point scale, 0 (no crusting) to 3 (severe crusting)
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.
Measured: Day 5, 8 and 15
Localized skin response to Swelling is measured using a 4 point scale, 0 (no swelling) to 3 (severe swelling)
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.
Measured: 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)
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.
Measured: Day 5, 8 and 15
VAS questionnaire - How much pain was associated with the use of Picato® for 3 days?
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).
Measured: Day 5
VAS questionnaire - How much pain was associated with the use of Picato® followed by PDT?
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).
Measured: Day 5
VAS questionnaire - How much pain did you experience in the PDT treatment area?
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).
Measured: 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.
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:
- Would you used this treatment again? (Yes, No)
- Talking all things into account, how satisfied or dissatisfied with the outcome of using this medication? (Very dissatisfied, Dissatisfied, Somewhat Satisfied, Satisfied, Extremely Satisfied)
- How does this treatment compare to the other treatments? (Worse, Slightly Worse, No Change, Slightly Better, Much Better)
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Actinic KeratosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pacific Dermaesthetics
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Jason K Rivers, MD, FRCPC, FAAD, Pacific Dermaesthetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354391
- Sponsor's protocol ID
- 1969699
- Status last verified
- Mar 2019
- First submitted
- 20 Jan 2015
- Last updated
- 26 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ingenol Mebutate (Picato®) With Methyl Aminolevulinate Photodynamic Therapy for the Treatment of Actinic Keratosis.
- ClinicalTrials.gov ID
- NCT02354391
- Acronym / sponsor ID
- 1969699
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Pacific DermaestheticsUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Jan 2015
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ingenol mebutate and MAL PDT | Experimental | Drug: Ingenol mebutate Picato® and MAL PDT day 1, day 5, Drug: Ingenol mebutate Picato® day 2, 3, 4, Procedure: MAL PDT day 5Participants 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingenol mebutate Picato® and MAL PDT day 1, day 5Also: Picato® 0.015% and MAL PDTTreatment of ingenol mebutate, Picato® 0.015% topical gel applied on day 1 followed by MAL PDT on day 5 | Drug | Ingenol mebutate and MAL PDT |
| Ingenol mebutate Picato® day 2, 3, 4Also: Picato® 0.015%Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4 | Drug | Ingenol mebutate and MAL PDT |
| MAL PDT day 5Also: MAL PDTMethyl aminolevulate combined with Photodynamic therapy at day 5 | Procedure or surgery | Ingenol mebutate and MAL PDT |
Primary outcome
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.
13 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ingenol mebutate Picato® and MAL PDT day 1, day 5, Ingenol mebutate Picato® day 2, 3, 4 and MAL PDT day 5 in people with Actinic Keratosis, run by Pacific Dermaesthetics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clearance of lesions (time frame: 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2019.