Actinic Keratosis (AK)Phase 4NCT02406014
Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
A Phase 4 study testing Ingenol Mebutate Gel, 0.015% and Diclofenac sodium gel 3% in people with Actinic Keratosis (AK), run by LEO Pharma at 1 site in Germany.
Trial summary
This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Actinic Keratosis (AK)
- What is being tested?
- Ingenol Mebutate Gel, 0.015% and Diclofenac sodium gel 3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 502 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Jun 2016
- Phase
- Phase 4
- 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
- Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp
Who cannot join
- 1. Location of the selected treatment area:
- on the periorbital skin
- on the perioral skin/around the nostrils
- within 5 cm of an incompletely healed wound
- within 10 cm of a suspected BCC or SCC or other neoplasia
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.
Read the detailed description
All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.
Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:
- Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
- Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
- Conditions
- Actinic Keratosis (AK)
- Being tested
- Ingenol Mebutate Gel, 0.015%, Diclofenac sodium gel 3%
- 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
Also called Picato®
Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
Diclofenac sodium gel 3%Drug
Also called Solaraze®
Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group A | Active comparator | Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days. Receives: Drug: Ingenol Mebutate Gel, 0.015% |
| Treatment Group B | Active comparator | Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days. Receives: Drug: Diclofenac sodium gel 3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance of all AKs
Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%
Measured: 11 Months
Secondary outcomes (1)
Complete clearance of all AKs at Week 17
As secondary response criteria, complete clearance at Week 17 for diclofenac sodium gel 3% will be compared with complete clearance in the ingenol mebutate 0.015% group.
Measured: 11 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completionJun 2016
- Study completionJun 2016
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 Keratosis (AK)Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eggert Stockfleth, Prof.Dr.med., Principal investigator, St. Josef-Hospital im Katholischen Klinikum Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406014
- Sponsor's protocol ID
- LP0041-1120
- Status last verified
- May 2017
- First submitted
- 27 Mar 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Stockfleth E, Harwood CA, Serra-Guillen C, Larsson T, Osterdal ML, Skov T. Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp. Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.
PubMed 29030864
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
- Efficacy and Safety of Ingenol Mebutate Gel 0.015% Compared to Diclofenac Sodium Gel 3% in Subjects With Actinic Keratoses on the Face or Scalp
- ClinicalTrials.gov ID
- NCT02406014
- Acronym / sponsor ID
- LP0041-1120
- Conditions
- Actinic Keratosis (AK)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Apr 2015 (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 a phase 4, multi-centre, randomized, two group, open label, active controlled, parallel group, 17 week trial.
Detailed description
All subjects who qualify for this trial are to have 4 to 8 clinically typical, visible and discrete AK lesions within a contiguous 25 cm2 treatment area on the face or scalp.
Eligible subjects will be randomised in a 1:1 ratio to the following treatment groups:
- Treatment Group A: Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days.
- Treatment Group B: Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group A | Active comparator | Drug: Ingenol Mebutate Gel, 0.015%Ingenol mebutate gel 0.015%, once daily for 3 consecutive days for the first treatment course. At 8 weeks after treatment initiation, subjects who present with existing AKs or newly emergent AKs in the treatment area will receive one more treatment course of ingenol mebutate gel 0.015%, daily for 3 consecutive days. |
| Treatment Group B | Active comparator | Drug: Diclofenac sodium gel 3%Diclofenac sodium gel 3%, (0.5 grams), twice daily for 90 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Following verbal and written information about the trial, subject must provide informed consent documented by signing the Informed Consent Form (ICF) prior to any trial related procedures
- Subjects with 4 to 8 clinically typical, visible and discrete AKs within a contiguous 25 cm² treatment area on the face or scalp
Key exclusion criteria (5 listed)
- on the periorbital skin
- on the perioral skin/around the nostrils
- within 5 cm of an incompletely healed wound
- within 10 cm of a suspected BCC or SCC or other neoplasia
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%Also: Picato®Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs. | Drug | Treatment Group A |
| Diclofenac sodium gel 3%Also: Solaraze®Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days. | Drug | Treatment Group B |
Primary outcome
Complete clearance of all AKs
Time frame: 11 Months
Complete clearance of all AKs in the treatment field at Week 8 for ingenol mebutate gel 0.015% and Week 17 for diclofenac sodium gel 3%
1 secondary outcome
Complete clearance of all AKs at Week 17
Time frame: 11 Months
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 29030864Stockfleth E, Harwood CA, Serra-Guillen C, Larsson T, Osterdal ML, Skov T. Phase IV head-to-head randomized controlled trial comparing ingenol mebutate 0.015% gel with diclofenac sodium 3% gel for the treatment of actinic keratosis on the face or scalp. Br J Dermatol. 2018 Feb;178(2):433-442. doi: 10.1111/bjd.16048. Epub 2018 Jan 15.
- 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.
Eggert Stockfleth, Prof.Dr.med. principal investigator
St. Josef-Hospital im Katholischen Klinikum Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ingenol Mebutate Gel, 0.015% and Diclofenac sodium gel 3% in people with Actinic Keratosis (AK), 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 2 inclusion and 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Complete clearance of all AKs (time frame: 11 Months). 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 NCT02406014, 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.