Actinic KeratosisPhase 3NCT01600014
Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
A Phase 3 study testing Ingenol mebutate gel, 0.015% in people with Actinic Keratosis, run by LEO Pharma at 13 sites in 5 countries.
Trial summary
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field. 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, 0.015%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 463 participants
- Where
- 13 sitesin 5 countries
- Study dates
- May 2012to Feb 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subjects must provide informed consent
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp
- Subject at least 18 years of age
- 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 study treatment, to rule out pregnancy
- Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception
Who cannot join
- Location of the selected treatment area:
- on any location other than the face or scalp
- on the periorbital skin
- 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 on face or scalp (previous treatment on trunk and extremities acceptable)
Show all 28Show fewer
- Selected treatment area lesions that have atypical clinical appearance
- History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
- Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle
- Known sensitivity or allergy to any of the ingredients in ingenol mebutate gel
- Presence of sunburn within the selected treatment area
- Current enrollment or participation in a clinical trial within 30 days of entry into this study
- Subjects previously entered first treatment in the trial
- Female subjects who are breastfeeding
- Subjects who are institutionalised by court order or by the local authority
- In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol
- Prohibited Therapies and/or Medications within 2 weeks prior to Day 1
- Cosmetic or therapeutic procedures within 2 cm of the selected treatment area
- Use of keratolytic topical therapeutic products within 2 cm of the selected treatment area
- Use of topical medicated creams, ointments, lotions gels, foams or sprays within 2 cm of the selected treatment area; artificial tanners: within 5 cm of the selected treatment area
- Prohibited Therapies and/or Medications: within 4 weeks prior to Day 1
- Treatment with immunomodulators, cytotoxic drugs or interferon /interferon inducers
- Treatment with systemic medications that suppress the immune system
- Treatment/therapy with ultraviolet light A (UVA) or ultraviolet light B (UVB)
- Prohibited Therapies and/or Medications within 8 weeks prior to Day 1
- Treatment with 5-fluorouracil (5-FU), imiquimod, diclofenac sodium, or photodynamic therapy: within 2 cm of the selected treatment area
- Prohibited Therapies and/or Medications within 6 months prior to Day 1
- Use of systemic retinoids or biologic/monoclonal antibody therapies
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Canada9 sites
UltraNova Skincare
Barrie, Ontario, L4M 6L2
Stratica Medical
Edmonton, Alberta, T5K 1X3
Durondel C.P. Inc./Dermatology Clinic
Moncton, New Brunswick, E1C 8X3
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
Centre de Recherche Dermatologique
Québec, Quebec, G1V 4X7
Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
Dermadvances Research
Winnipeg, Manitoba, R3C 1R4
United Kingdom1 site
Central Manchester University Hosptial
Manchester, Greater Manchester, M13 9WL
About this study
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.
- Conditions
- Actinic Keratosis
- Being tested
- Ingenol mebutate gel, 0.015%, Vehicle gel
- 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, 0.015%Drug
Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
Vehicle gelDrug
Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
| Study group | Role | What they receive |
|---|---|---|
| Ingenol mebutate gel, 0.015% | Active comparator | Topical field treatment once daily for 3 consecutive days on the face or scalp Receives: Drug: Ingenol mebutate gel, 0.015% |
| Vehicle gel | Placebo comparator | Topical field treatment once daily for 3 consecutive days on the face or scalp Receives: Drug: Vehicle gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)
Measured: 8 weeks after randomisation
Secondary outcomes (2)
Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12
The analysis was done separately for the field recalcitrant subgroup, the field recurrent subgroup, and overall for all treated subject (Analysis 1, 2, and 3, respectively)
Measured: From last treatment cycle through to Month 12
The Change in AK Count From Randomisation to 8 Weeks After Randomisation
The change in AK count from randomisation to 8 weeks after randomisation was determined for the field recalcitrant and the field recurrent subgroups
Measured: 8 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 463 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claus Garbe, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600014
- Sponsor's protocol ID
- LP0041-22
- Other IDs
- 2011-005018-13
- Status last verified
- Apr 2016
- First submitted
- 14 May 2012
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ingenol Mebutate Gel, 0.015% Repeat Use for Multiple Actinic Keratoses on Face and Scalp
- ClinicalTrials.gov ID
- NCT01600014
- Acronym / sponsor ID
- LP0041-22
- Conditions
- Actinic Keratosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 463 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 9 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to demonstrate that ingenol mebutate gel is efficacious in treating Actinic Keratoses (AKs) present 8 weeks after initial field treatment or emerging in a previously cleared field.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ingenol mebutate gel, 0.015% | Active comparator | Drug: Ingenol mebutate gel, 0.015%Topical field treatment once daily for 3 consecutive days on the face or scalp |
| Vehicle gel | Placebo comparator | Drug: Vehicle gelTopical field treatment once daily for 3 consecutive days on the face or scalp |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects must provide informed consent
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm2 treatment area on the face or scalp
- Subject at least 18 years of age
- Female subjects must be of either:
- Female subjects of childbearing potential must be willing to consent to using highly effective methods of contraception
Key exclusion criteria (28 listed)
- Location of the selected treatment area:
- Prior treatment with ingenol mebutate gel on face or scalp (previous treatment on trunk and extremities acceptable)
- Selected treatment area lesions that have atypical clinical appearance
- History or evidence of skin conditions other than the trial indication that would interfere with evaluation of the trial medication in the selected treatment area
- Anticipated need for hospitalization or out-patient surgery prior to Day 15 in the first treatment cycle
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, 0.015%Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015% | Drug | Ingenol mebutate gel, 0.015% |
| Vehicle gelTopical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015% | Drug | Vehicle gel |
Primary outcome
Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation
Time frame: 8 weeks after randomisation
The complete clearance rates 8 weeks after randomisation was compared between ingenol mebutate gel, 0.015% and vehicle gel. Complete clearance was defined as no clinically visible AKs in the Selected Treatment Area (STA)
2 secondary outcomes
Number of Participants With Complete Clearance Through to Month 12, Defined as no Clinically Visible AKs and no Lesions Treated in the Selected Treatment Area at Any Time From Last Treatment Cycle Through to Month 12
Time frame: From last treatment cycle through to Month 12
The Change in AK Count From Randomisation to 8 Weeks After Randomisation
Time frame: 8 weeks after randomisation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Clinical Trials at LEO PharmaLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Actinic Keratosis
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma
Active, not recruitingPhase 4
Cryotherapy in Combination With Red Light PDT for Actinic Keratosis of Full Face
Actinic Keratoses
Not yet recruiting
Therapeutic Induction of Dermal Remodeling in Veterans to Prevent Actinic Neoplasia Caused by Chronic Environmental Exposure to Ultraviolet Radiation
Nonmelanoma Skin Cancer, Actinic Keratosis
Not yet recruitingPhase 1
5-Fluorouracil and Calcipotriene for Field Treatment of Actinic Keratoses
Actinic Keratoses
Recruiting
Multimodal Laser Treatment of Photodamaged Skin
Photo-damage, Actinic Keratosis (AK)
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.
Claus Garbe, MD principal investigator
University Hospital Tuebingen
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ingenol mebutate gel, 0.015% in people with Actinic Keratosis, run by LEO Pharma at 13 sites in 5 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 7 inclusion and 28 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 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Canada, Australia, France, Germany, United Kingdom. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Complete Clearance of AKs 8 Weeks After Randomisation (time frame: 8 weeks after randomisation). 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 10 Mar 2025; AzTrials last refreshed its copy on 31 Oct 2026.