Actinic KeratosisPhase 1NCT01892137
Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
A Phase 1 study testing Ingenol mebutate gel 0.05% in people with Actinic Keratosis, run by LEO Pharma at 10 sites in 2 countries.
Trial summary
The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard. 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 gel 0.05%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 137 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Jul 2013to May 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
- Must be male or female and at least 18 years of age.
- Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
- Ability to provide informed consent
- Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
- AK should be confirmed by histopathology of one of the AK's prior to inclusion
Who cannot join
- location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
- undergone Cosmetic or therapeutic procedures
- use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
- use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
- treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
- treatment with 5-FU, imiquimod, diclofenac, ingenol mebutate of photodynamic therapy within 2cm of the treatment area in the 8 weeks prior to visit 1
Show all 10Show fewer
- use of systemic retinoids
- those who are currently participating in any other interventional clinical trial
- females who are pregnant or are breastfeeding
- those known or suspected of not being able to comply with the requirements of the protocol or provide consent
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Australia6 sites
The Skin Centre
Benowa, Queensland, 4217
South East Dermatology Centre
Carina Heights, Queensland, 4152
Southderm Pty Ltd
Kogarah, New South Wales, 2217
Melanoma Institute Australia
North Sydney, New South Wales, 2060
St John of God Dermatology
Subiaco, Western Australia, 6008
Burswood Dermatology
Victoria Park, Western Australia, 6100
Germany4 sites
Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd
Augsburg, 86179
Collegium Medicum Berlin GmbH
Berlin, 10117
Medizinisches Zentrum Bonn Friedensplatz
Bonn, 42275
Hautarztpraxis Prof. Dr. med. C. Termeer
Stuttgart, 70499
About this study
The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate gel 0.05%
- Keywords
- Actinic Keratosis, Histopathology, Reflectance Confocal Microscopy, Local Skin Reaction
- 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 gel 0.05%Drug
Once daily for 2 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Open label active | Other | Not described Receives: Drug: Ingenol mebutate gel 0.05% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearance of AK
The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).
Measured: 8 weeks
Secondary outcomes (1)
Complete clearance of AKs in the Selected Treatment Area
Efficacy in terms of complete clearance of AKs in the STA and histological clearance of pre-identified lesion. AK clearance will be determined by AK count. Clearance of the pre-identified lesion will be assessed by a histopatholgist from a biopsy sample and reported as AK or not AK.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionMay 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martina Ulrich, Principal investigator, Collegium Medicum Berlin GmbH, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892137
- Sponsor's protocol ID
- LP0041-62
- Status last verified
- Mar 2015
- First submitted
- 23 Jun 2013
- 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
- Histological Confirmation of Clinical Clearance of Actinic Keratoses Following Treatment With Ingenol Mebutate Gel, 0.05%
- ClinicalTrials.gov ID
- NCT01892137
- Acronym / sponsor ID
- LP0041-62
- Conditions
- Actinic Keratosis
- Keywords
- Actinic Keratosis, Histopathology, Reflectance Confocal Microscopy, Local Skin Reaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 4 Jul 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.
The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open label active | Other | Drug: Ingenol mebutate gel 0.05% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be male or female and at least 18 years of age.
- Female patients must be on non-childbearing potential or if of childbearing potential then negative serum and urine pregnancy test and using effective contraception
- Ability to provide informed consent
- Subjects must have 5-9 clinically typical, visible and discrete AK lesions within a contiguous 25cm2 treatment area on the trunk and extremities except the back of the hand
- AK should be confirmed by histopathology of one of the AK's prior to inclusion
Key exclusion criteria (10 listed)
- location of the selected treatment area within 5cm of an incompletely healed wound or within 10cm of a suspected basal cell carcinoma or squamous cell carcinoma
- undergone Cosmetic or therapeutic procedures
- use of acid-containing therapeutic products within 2cm of the selected treatment area in the 2 weeks prior to Visit 1
- use of topical creams/lotions, artificial tanners or topical steroids within 2cm of the selected treatment areas in the 2 weeks prior to visit 1.
- treatment with immunomodulators, or interferon/interferon inducers or systemic medications that suppress the immune system within 4 weeks of visit 1
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 gel 0.05%Once daily for 2 consecutive days | Drug | Open label active |
Primary outcome
Clearance of AK
Time frame: 8 weeks
The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK).
1 secondary outcome
Complete clearance of AKs in the Selected Treatment Area
Time frame: 8 weeks
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.
- LEO PharmaLink provided by the sponsor.
- Therapeutic Goods AdministrationLink provided by the sponsor.
- 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.
Martina Ulrich principal investigator
Collegium Medicum Berlin GmbH, Germany
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ingenol mebutate gel 0.05% in people with Actinic Keratosis, run by LEO Pharma at 10 sites in 2 countries.
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 5 inclusion and 10 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 10 sites in Australia, Germany. 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?
Clearance of AK (time frame: 8 weeks). 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.