Actinic KeratosisPhase 1NCT01387711
PEP005 Gel - Biological Effects in Actinic Keratosis Assessed by Histology
A Phase 1 study testing PEP005 (Ingenol mebutat Gel, 0.05 %) in people with Actinic Keratosis, run by LEO Pharma at 1 site in Germany.
Trial summary
This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology. 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?
- PEP005 (Ingenol mebutat Gel, 0.05 %)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jun 2012
- 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
- Male or female patients at least 18 years of age
- Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
- Patients with a 25 cm2 area of normal skin on the upper inner arm
- Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
- Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
- Ability to follow study instructions and likely to complete all study requirements
- Obtained written informed consent prior to any study-related procedures
Who cannot join
- Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
- Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety, as determined by Investigator clinical judgment.
- Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
- Current participation in any other interventional clinical trial
- Subjects who have received treatment with any non-marketed drug product within the last two months
Show all 14Show fewer
- Subject known or, in the opinion of the investigator, is unlikely to comply with the Clinical Study Protocol
- Females who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding
- Undergone cosmetic or therapeutic procedures within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
- Use of acid-containing therapeutic products within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
- Use of topical salves/topical steroids: within 2 cm of the selected treatment areas in the 2 weeks prior to the screening visit
- Treatment with immunomodulators, cytotoxic drugs or interferon/interferon inducers, systemic medications that suppress the immune system or UVB in the last 4 weeks
- Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy: within 2 cm of the selected treatment areas within 8 weeks prior to any screening visit
- Use of systemic retinoids
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin Göttingen, Georg-August-Universität
Göttingen, D-37075
About this study
Official title: A Phase I, Single-centre, Open Label, Within-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Patients With Actinic Keratosis on the Upper Extremity
This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.
- Conditions
- Actinic Keratosis
- Being tested
- PEP005 (Ingenol mebutat Gel, 0.05 %)
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEP005 (Ingenol mebutat Gel, 0.05 %)Drug
All eligible patients will receive PEP005 Gel, 0.05 %, on two consecutive days to both the AK Treatment Area and the Normal Skin Treatment Area
| Study group | Role | What they receive |
|---|---|---|
| ingenol mebutate | Experimental | PEP gel 0.05% once daily exposure Receives: Drug: PEP005 (Ingenol mebutat Gel, 0.05 %) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leukocytes Infiltration and degree of necrosis of the AK lesion and skin
Degree of skin infiltration of leukocytes and necrosis of the epidermis and dermis in the AK biopsies from Day 1, Day 2, and Day 3
Measured: From baseline until day 3
Secondary outcomes (1)
Biological effects in the skin
- Leukocytes Infiltration
- Degree of skin infiltration of leukocytes
- Necrosis
- Haemorrhage
- Immune cell activation
- Apoptosis
- Endothelium activation
- RNA expression
- Drug Transporter
Number of participants with changes in normal skin and AK lesion biopsies
Measured: from baseline till day day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael P Schön, MD, Principal investigator, Universitätsmedizin Göttingen, Georg-August-Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01387711
- Sponsor's protocol ID
- LP0041-02
- Status last verified
- Dec 2016
- First submitted
- 1 Jul 2011
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Emmert S, Haenssle HA, Zibert JR, Schon M, Hald A, Hansen MH, Litman T, Schon MP. Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate. PLoS One. 2016 Sep 9;11(9):e0160096. doi: 10.1371/journal.pone.0160096. eCollection 2016.
PubMed 27612149
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, Single-centre, Open Label, Within-subject Comparison Trial to Explore the Biological Effects of PEP005 (Ingenol Mebutate) Gel, 0.05%, Applied Once Daily for 2 Consecutive Days in Patients With Actinic Keratosis on the Upper Extremity
- ClinicalTrials.gov ID
- NCT01387711
- Acronym / sponsor ID
- LP0041-02
- Conditions
- Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 4 Jul 2011 (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 trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ingenol mebutate | Experimental | Drug: PEP005 (Ingenol mebutat Gel, 0.05 %)PEP gel 0.05% once daily exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female patients at least 18 years of age
- Patients with AK lesions within a contiguous 25 cm2 area on the upper extremity
- Patients with a 25 cm2 area of normal skin on the upper inner arm
- Female subjects must be of either non-childbearing potential or childbearing potential, provided there is a confirmed negative urine pregnancy test prior to exposure, to rule out pregnancy
- Female subjects of childbearing potential must be willing to consent to using high effective methods of contraception
Key exclusion criteria (14 listed)
- Location of the selected treatment areas within 5 cm of an incompletely healed wound within 10 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
- History or evidence of skin conditions other than the study indication that would interfere with evaluation of the study medication
- Clinical diagnosis/history or evidence of any medical condition that would expose a subject to an undue risk of a significant AE or interfere with assessments of safety, as determined by Investigator clinical judgment.
- Anticipated need for in-patient hospitalisation or in-patient surgery during the study period.
- Current participation in any other interventional clinical 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 |
|---|---|---|
| PEP005 (Ingenol mebutat Gel, 0.05 %)All eligible patients will receive PEP005 Gel, 0.05 %, on two consecutive days to both the AK Treatment Area and the Normal Skin Treatment Area | Drug | ingenol mebutate |
Primary outcome
Leukocytes Infiltration and degree of necrosis of the AK lesion and skin
Time frame: From baseline until day 3
Degree of skin infiltration of leukocytes and necrosis of the epidermis and dermis in the AK biopsies from Day 1, Day 2, and Day 3
1 secondary outcome
Biological effects in the skin
Time frame: from baseline till day day 3
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.
- Derived from this study: PubMed 27612149Emmert S, Haenssle HA, Zibert JR, Schon M, Hald A, Hansen MH, Litman T, Schon MP. Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate. PLoS One. 2016 Sep 9;11(9):e0160096. doi: 10.1371/journal.pone.0160096. eCollection 2016.
- 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.
Michael P Schön, MD principal investigator
Universitätsmedizin Göttingen, Georg-August-Universität
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 PEP005 (Ingenol mebutat Gel, 0.05 %) in people with Actinic Keratosis, run by LEO Pharma at 1 site in Germany.
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 14 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 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?
Leukocytes Infiltration and degree of necrosis of the AK lesion and skin (time frame: From baseline until day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01387711, which also lists 1 linked publication.
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.