Actinic KeratosisPhase 1NCT01836367
Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
A Phase 1 study testing Ingenol Mebutate 0.015% in people with Actinic Keratosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis
- What is being tested?
- Ingenol Mebutate 0.015%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Aug 2013
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years old.
- Subjects must be in good general health as confirmed by the medical history.
- Subjects must be able to read, sign, and understand the informed consent
- Subjects have at least 4-8 clinically typical, visible, non-hypertrophic actinic keratoses on the face or scalp in a 25 cm2 area.
- Subject must be willing to forego any other treatments on the face or scalp, including tanning bed use and excessive sun exposure while in the study.
- Subject is willing and able to participate in the study as an outpatient, making frequent visits to the study center during the treatment and follow-up periods and to comply with all study requirements including concomitant medication and other treatment restrictions.
- If subject is a female of childbearing potential she must have a negative urine pregnancy test result prior to study treatment initiation and must agree to use an approved method of birth control while enrolled in the study.
Who cannot join
- Subjects with a history of melanoma anywhere on the body.
- The second cycle of ingenol mebutate 0.015% should only be applied if the skin is healed from the first cycle of ingenol mebutate 0.015%.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with non-melanoma skin cancer on the face or scalp.
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
- Subjects who have previously been treated with ingenol mebutate: on the face or scalp in the past 6 months; or outside of the study area within the past 30 days.
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- Women who are pregnant, lactating, or planning to become pregnant during the study period.
- Subjects who have experienced a clinically important medical event within 90 days of the visit (e.g., stroke, myocardial infarction, etc).
- Subjects who have active chemical dependency or alcoholism as assessed by the investigator.
- Subjects who have known allergies to any excipient in the study gel.
- Subjects who are currently participating in another clinical study or have completed another clinical study with an investigational drug or device on the study area within 30 days prior to study treatment initiation.
- Subjects who have received any of the following within 90 days prior to study treatment initiation:
- interferon or interferon inducers
- cytotoxic drugs
- immunomodulators or immunosuppressive therapies (inhaled/ intranasal steroids are permitted)
- oral or parenteral corticosteroids
- topical corticosteroids if greater than 2 gm/day
- any dermatologic procedures or surgeries on the study area (including any AK treatments)
- Subjects who have used any topical prescription medications on the study area within 30 days prior to study treatment initiation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage, topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for therapy, however as with other lesion-directed therapies, cryosurgery does not treat subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel 0.015% has shown to not only have a high clearance rate but also a transient localized inflammatory skin response that resolves quickly without sequelae. However, one common fear about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin, and that retreatment would produce an equally, if not more, caustic result on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower LSR scores compared to the LSR in the first cycle of application. We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles.
Read the detailed description
We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles. For the first cycle of study application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1 baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale (VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15, in which LSR will be assessed and photographs taken. Approximately four weeks later, a second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied to the same treatment area on the face or scalp. Subjects will be followed during treatment on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken. Post-treatment follow-up for the second cycle of application will occur on day 36, day 43, and day 56. During these post-treatment follow-up visits LSR and photographs will be taken. LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29 and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol Mebutate 0.015%
- Keywords
- Actinic Keratosis, Face, Scalp, Ingenol Mebutate
- Medical subject headings
- Keratosis, Actinic, Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ingenol Mebutate 0.015%Drug
Also called ingenol mebutate 0.015% qdaily x 3 days for two cycles
Picato
| Study group | Role | What they receive |
|---|---|---|
| Ingenol Mebutate 0.015% | Experimental | two cycles of ingenol mebutate 0.015% Receives: Drug: Ingenol Mebutate 0.015% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of Irritation after two cycles of ingenol mebutate
To evaluate the degree of irritation, as measured by local skin reactions (LSR), after a second cycle of ingenol mebutate gel to the face or scalp through photography assessed by a blinded observer.
Measured: up to 1 year
Secondary outcomes (1)
Degree of Irritation 1 day post application of first and second cycle of ingenol mebutate
To evaluate and compare the degree of irritation, as measured by LSR, that occurs one (1) day post-application of the first and second cycle of ingenol mebutate gel to the face or scalp.
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
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.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- LEO Pharma
- Responsible party
- Principal investigator, Mark Lebwohl, Icahn School of Medicine at Mount Sinai
- Investigators
- Mark Lebwohl, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836367
- Sponsor's protocol ID
- GCO 13-0026
- Status last verified
- Dec 2013
- First submitted
- 17 Apr 2013
- Last updated
- 31 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Study to Assess the Degree of Irritation After a Second Cycle of Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
- ClinicalTrials.gov ID
- NCT01836367
- Acronym / sponsor ID
- GCO 13-0026
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Face, Scalp, Ingenol Mebutate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- LEO Pharma
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 19 Apr 2013 (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.
Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodesiccation and curettage, topical chemotherapy and light therapies. Cryosurgery is considered the gold standard for therapy, however as with other lesion-directed therapies, cryosurgery does not treat subclinical lesions in the surrounding skin. Ingenol mebutate is the active compound in the sap from Euphorbia peplus L. (E. peplus). Topical ingenol mebutate treatment has been approved for the treatment of AKs. The goal of AK therapy for all physicians is to provide an effective, tissue-sparing treatment with good cosmetic results. Ingenol mebutate gel 0.015% has shown to not only have a high clearance rate but also a transient localized inflammatory skin response that resolves quickly without sequelae. However, one common fear about ingenol mebutate is that it's mechanism of action is purely destructive to both AKs and healthy skin, and that retreatment would produce an equally, if not more, caustic result on the skin such as severe erosion, scaling, and erythema. It is our hope to debunk this misconception and demonstrate that reapplication of a second cycle of ingenol mebutate would result in lower LSR scores compared to the LSR in the first cycle of application. We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles.
Detailed description
We plan to treat 20 subjects. Each qualifying subject will have at least 4-8 non-hypertrophic AKs in a 25 cm2 treatment area on the face or scalp. All subjects will be treated with two cycles of ingenol mebutate 0.015%. The first cycle will be started on Day 1, and the second cycle will be started on Day 29 (four weeks apart). Subjects will utilize the once daily for three days regimen for both cycles. For the first cycle of study application, subjects will be followed on day 1, day 2, and day 4 during treatment; on day 1 baseline photographs will be taken, on day 2 LSR will be assessed and visual analog scale (VAS) regarding perceived irritation will be conducted, and on day 4 LSR, VAS and photographs will be taken. Post-treatment follow-up will be conducted on day 8 and day 15, in which LSR will be assessed and photographs taken. Approximately four weeks later, a second cycle of once daily for three day regimen of ingenol mebutate 0.015% will be applied to the same treatment area on the face or scalp. Subjects will be followed during treatment on day 29, day 30 and day 32; on day 29 LSR and photographs will be taken, on day 30 LSR will be assessed and VAS conducted, and on day 32 LSR, VAS and photographs will be taken. Post-treatment follow-up for the second cycle of application will occur on day 36, day 43, and day 56. During these post-treatment follow-up visits LSR and photographs will be taken. LSR scores from day 4 and day 32 will be assessed by a blinded observer. Lastly, on day 29 and day 56 the patient's treatment satisfaction will be evaluated on a 10 point visual analog scale (VAS). Consequently, there will be a total of 11 visits during a 56 day period.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ingenol Mebutate 0.015% | Experimental | Drug: Ingenol Mebutate 0.015%two cycles of ingenol mebutate 0.015% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults at least 18 years old.
- Subjects must be in good general health as confirmed by the medical history.
- Subjects must be able to read, sign, and understand the informed consent
- Subjects have at least 4-8 clinically typical, visible, non-hypertrophic actinic keratoses on the face or scalp in a 25 cm2 area.
- Subject must be willing to forego any other treatments on the face or scalp, including tanning bed use and excessive sun exposure while in the study.
Key exclusion criteria (19 listed)
- Subjects with a history of melanoma anywhere on the body.
- The second cycle of ingenol mebutate 0.015% should only be applied if the skin is healed from the first cycle of ingenol mebutate 0.015%.
- Subjects with an unstable medical condition as deemed by the clinical investigator.
- Subjects with non-melanoma skin cancer on the face or scalp.
- Subjects with any dermatologic disease in the treatment area that may be exacerbated by the treatment proposed or that might impair the evaluation of AKs.
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 0.015%Also: ingenol mebutate 0.015% qdaily x 3 days for two cyclesPicato | Drug | Ingenol Mebutate 0.015% |
Primary outcome
Degree of Irritation after two cycles of ingenol mebutate
Time frame: up to 1 year
To evaluate the degree of irritation, as measured by local skin reactions (LSR), after a second cycle of ingenol mebutate gel to the face or scalp through photography assessed by a blinded observer.
1 secondary outcome
Degree of Irritation 1 day post application of first and second cycle of ingenol mebutate
Time frame: up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2013.
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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.
Mark Lebwohl, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ingenol Mebutate 0.015% in people with Actinic Keratosis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
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 7 inclusion and 19 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: finished, as of the sponsor's last update on 31 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of Irritation after two cycles of ingenol mebutate (time frame: up to 1 year). 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 31 Dec 2013.