Actinic KeratosisPhase 1NCT02124239
Pharmacokinetics of Ingenol Mebutate Gel in Actinic Keratosis Under Maximum Use Conditions
A Phase 1 study testing Ingenol mebutate in people with Actinic Keratosis, run by LEO Pharma at 1 site in United States.
Trial summary
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face, balding scalp or on… 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Nov 2014
- 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
- 1. Following verbal and written information about the trial, the subject must provide informed consent documented by signing the Informed Consent Form prior to any trial-related procedures.2. Subjects with at least 10 clinically typical, visible and discrete AKs on the face, on approximately 250 cm2 of balding scalp or an area of approximately 250 cm2 of sun-damaged skin on the arm except the back of the hand.
- 3. Subject at least 18 years of age. 4. Female subjects must be of either:
- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
- Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment, to rule out pregnancy.
- 5. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion. Effective contraception is defined as follows:
- Oral/implant/injectable/transdermal/oestrogenic vaginal ring contraceptives, intrauterine device, condom with spermicide, diaphragm with spermicide.
- Abstinence or partner's vasectomy are acceptable if the female agrees to implement one of the other acceptable methods of birth control if her partner changes.
Who cannot join
- Location of the treatment area (full face, balding scalp or arm)
- within 5 cm of an incompletely healed wound,
- within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC).
- Prior treatment with ingenol mebutate gel within the last three months.
- Lesions in the treatment areas that have:
- atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or,
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- recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
- Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment.
- Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency or psychotic state).
- Subjects with QTcF interval > 450 ms for males and 470 ms for females or other relevant pathological changes in the ECG in opinion of the investigator. These intervals apply at Screening Visit.
Trial locations and contacts
1 site in 1 country.
United States1 site
Academic Dermatology Associate
Albuquerque, New Mexico, 47106
About this study
Official title: A Phase I, Multi-centre, Open-label, Uncontrolled, Non-randomised Study to Evaluate the Systemic Exposure and Safety of Ingenol Mebutate When Applied to Full Face, Balding Scalp or an Area of Approximately 250 cm2 on the Arm in Subjects With Actinic Keratosis
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups.
To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face, balding scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027% on the full face for three consecutive days, (2) the same regimen on the balding scalp, and (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of approximately 250 cm2 for four consecutive days.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate
- 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 mebutateDrug
| Study group | Role | What they receive |
|---|---|---|
| Scalp | Experimental | Treatment of scalp with 0.027% ingenol mebutate once daily for 3 days Receives: Drug: Ingenol mebutate |
| Arm | Experimental | Treatment of arm with 0.06% ingenol mebutate once daily for 4 days Receives: Drug: Ingenol mebutate |
| Face | Experimental | Treatment of face with 0.027% ingenol mebutate once daily for 3 days Receives: Drug: Ingenol mebutate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC)
Measured: Once daily for four or five days
Peak Plasma Concentration (Cmax)
Measured: Once daily for four or five days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2014
- Study completionNov 2014
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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alicia D Bucko, MD, Principal investigator, Academic Dermatology Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02124239
- Sponsor's protocol ID
- LP0105-1034
- Status last verified
- Jun 2016
- First submitted
- 23 Apr 2014
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-centre, Open-label, Uncontrolled, Non-randomised Study to Evaluate the Systemic Exposure and Safety of Ingenol Mebutate When Applied to Full Face, Balding Scalp or an Area of Approximately 250 cm2 on the Arm in Subjects With Actinic Keratosis
- ClinicalTrials.gov ID
- NCT02124239
- Acronym / sponsor ID
- LP0105-1034
- Conditions
- Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Apr 2014 (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.
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups.
To be eligible for inclusion in this trial, subjects must have at least 10 clinically typical, visible, and discrete AKs on the face, balding scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of ingenol mebutate gel 0.027% on the full face for three consecutive days, (2) the same regimen on the balding scalp, and (3) once daily application of ingenol mebutate gel 0.06% on the arm on a treatment area of approximately 250 cm2 for four consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Scalp | Experimental | Drug: Ingenol mebutateTreatment of scalp with 0.027% ingenol mebutate once daily for 3 days |
| Arm | Experimental | Drug: Ingenol mebutateTreatment of arm with 0.06% ingenol mebutate once daily for 4 days |
| Face | Experimental | Drug: Ingenol mebutateTreatment of face with 0.027% ingenol mebutate once daily for 3 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1. Following verbal and written information about the trial, the subject must provide informed consent documented by signing the Informed Consent Form prior to any trial-related procedures.2. Subjects with at least 10 clinically typical, visible and discrete AKs on the face, on approximately 250 cm2 of balding scalp or an area of approximately 250 cm2 of sun-damaged skin on the arm except the back of the hand.
- Non-childbearing potential, i.e. post-menopausal or have a confirmed clinical history of sterility (e.g. the subject is without a uterus) or,
- 5. Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion. Effective contraception is defined as follows:
Key exclusion criteria (11 listed)
- Location of the treatment area (full face, balding scalp or arm)
- Prior treatment with ingenol mebutate gel within the last three months.
- Lesions in the treatment areas that have:
- Any abnormal laboratory tests that are medically significant and would impact the safety of the subjects or the interpretation of the trial results, as determined by the investigator's judgment.
- Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
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 | Drug | Arm, Face, Scalp |
Primary outcome
Area under the plasma concentration versus time curve (AUC)
Time frame: Once daily for four or five days
Peak Plasma Concentration (Cmax)
Time frame: Once daily for four or five days
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 24 Feb 2025.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alicia D Bucko, MD principal investigator
Academic Dermatology Associates
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 in people with Actinic Keratosis, run by LEO Pharma 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 11 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 24 Feb 2025. 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?
Area under the plasma concentration versus time curve (AUC) (time frame: Once daily for four or five days). The study lists 2 primary outcomes in all. 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 24 Feb 2025.