Actinic KeratosisPhase 2NCT02305888
Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
A Phase 2 study testing LEO 43204 in people with Actinic Keratosis, run by LEO Pharma at 1 site in United States.
Trial summary
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively. 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?
- LEO 43204
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Aug 2015
- Phase
- Phase 2
- 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 with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
- The full face
- The full balding scalp
- A contiguous area of approximately 250 cm2 on trunk or extremities
Who cannot join
- Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
- Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
- Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months
- Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Skin Cancer and Dermatologic Surgery
Smithtown, New York, 11787
About this study
Official title: Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.
- Conditions
- Actinic Keratosis
- Being tested
- LEO 43204
- Medical subject headings
- Keratosis, Actinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 43204Drug
Treatment of actinic keratosis
| Study group | Role | What they receive |
|---|---|---|
| LEO 43204, 0.018% once daily for 3 days | Experimental | Not described Receives: Drug: LEO 43204 |
| LEO 43204, 0.037% once daily for 3 days | Experimental | Not described Receives: Drug: LEO 43204 |
| LEO 43204, 0.1% once daily for 3 days | Experimental | Not described Receives: Drug: LEO 43204 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
For face/chest, a DLT was defined as one or more of the following three LSRs:
- Crusting Grade 4
- Erosion/Ulceration Grade 4
- Vesiculation/Pustulation Grade 4
Or two or more of the following five LSRs:
- Erythema Grade 4
- Crusting Grade 3
- Swelling Grade 4
- Erosion/Ulceration Grade 3
- Vesiculation/Pustulation Grade 3
For scalp a DLT was defined as erosion/ulceration Grade 4
For trunk/extremities a DLT was defined as one or more of the following three LSRs:
- Crusting Grade 4
- Erosion/Ulceration Grade 4
- Vesiculation/Pustulation Grade 4
Or two or more of the following four LSRs:
- Crusting Grade 3
- Swelling Grade 4
- Erosion/Ulceration Grade 3
- Vesiculation/Pustulation Grade 3
Measured: 8 days / From baseline (Day 1) to Day 8
Secondary outcomes (3)
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at baseline (Day 1), Week 4, and Week 8. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
Measured: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Hypertrophic/Hyperkeratotic lesions were identified at baseline (Day 1), Week 4 and Week 8.
Measured: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percentage of Participants With Complete Clearance of AKs
Complete clearance was defined as no clinically visible AKs. This analysis excluded lesions identified at baseline as hypertrophic/hyperkeratotic.
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 posted3 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionJul 2015
- Study completionAug 2015
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.
- Publications (2)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Daniel M Siegel, MD, Principal investigator, Long Island Skin Cancer and Dermatologic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305888
- Sponsor's protocol ID
- LP0084-1148
- Status last verified
- Feb 2019
- First submitted
- 1 Dec 2014
- Last updated
- 10 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Siegel DM, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Berman B. Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial. J Clin Aesthet Dermatol. 2017 Dec;10(12):19-26. Epub 2017 Dec 1.
PubMed 29399263Berman B, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Siegel DM. Three-Day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: Cosmetic Outcomes and Patient Satisfaction from a Phase II Trial. J Clin Aesthet Dermatol. 2017 Nov;10(11):26-32. Epub 2017 Nov 1.
PubMed 29399258
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
- Safety of LEO 43204 0.018%, 0.037% and 0.1% for Actinic Keratosis Applied Once Daily for Three Consecutive Days on Face/Chest, Scalp and Trunk/Extremities, Respectively
- ClinicalTrials.gov ID
- NCT02305888
- Acronym / sponsor ID
- LP0084-1148
- Conditions
- Actinic Keratosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Dec 2014 (estimated)
- Results
- Posted 5 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1% for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and trunk/extremities, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LEO 43204, 0.018% once daily for 3 days | Experimental | Drug: LEO 43204 |
| LEO 43204, 0.037% once daily for 3 days | Experimental | Drug: LEO 43204 |
| LEO 43204, 0.1% once daily for 3 days | Experimental | Drug: LEO 43204 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:
- The full face
- The full balding scalp
- A contiguous area of approximately 250 cm2 on trunk or extremities
Key exclusion criteria (4 listed)
- Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.
- Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
- Treatment with ingenol mebutate gel in the selected treatment area within the last 12 months
- Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions).
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 |
|---|---|---|
| LEO 43204Treatment of actinic keratosis | Drug | LEO 43204, 0.018% once daily for 3 days, LEO 43204, 0.037% once daily for 3 days, LEO 43204, 0.1% once daily for 3 days |
Primary outcome
Number of Participants Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions)
Time frame: 8 days / From baseline (Day 1) to Day 8
For face/chest, a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following five LSRs: * Erythema Grade 4 * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 For scalp a DLT was defined as erosion/ulceration Grade 4 For trunk/extremities a DLT was defined as one or more of the following three LSRs: * Crusting Grade 4 * Erosion/Ulceration Grade 4 * Vesiculation/Pustulation Grade 4 Or two or more of the following four LSRs: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3
3 secondary outcomes
Percent Reduction in AK Count Excluding Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Time frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percent Reduction in AK Count of Lesions Identified at Baseline as Hypertrophic/Hyperkeratotic
Time frame: 4 weeks and 8 weeks / From baseline to Week 4, and Week 8
Percentage of Participants With Complete Clearance of AKs
Time frame: 8 weeks
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.
- Derived from this study: PubMed 29399263Siegel DM, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Berman B. Three-day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: A Phase II Trial. J Clin Aesthet Dermatol. 2017 Dec;10(12):19-26. Epub 2017 Dec 1.
- Derived from this study: PubMed 29399258Berman B, Tyring S, Nahm WK, Osterdal ML, Petersen AH, Siegel DM. Three-Day Field Treatment with Ingenol Disoxate (LEO 43204) for Actinic Keratosis: Cosmetic Outcomes and Patient Satisfaction from a Phase II Trial. J Clin Aesthet Dermatol. 2017 Nov;10(11):26-32. Epub 2017 Nov 1.
- 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.
Daniel M Siegel, MD principal investigator
Long Island Skin Cancer and Dermatologic Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LEO 43204 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 4 inclusion and 4 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 5 Mar 2019). 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 Experiencing DLTs (Dose Limiting Toxicities) Based on LSRs (Local Skin Reactions) (time frame: 8 days / From baseline (Day 1) to Day 8). 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 NCT02305888, which also lists 2 linked publications.
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.