Actinic KeratosisPhase 3NCT02549352

Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up

A Phase 3 study testing LEO43204 gel in people with Actinic Keratosis, run by LEO Pharma at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The objective of the trial is to compare the short term efficacy of LEO 43204 gel with vehicle gel in AK on the balding scalp when applied topically once daily for 3 consecutive days as field treatment 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?: LEO43204 gel
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 391 participants
Where: 1 siteGermany
Study dates: Nov 2015to Aug 2017
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 with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Who cannot join

Location of the treatment area (balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
Treatment with ingenol mebutate gel in the treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)

Trial locations and contacts

1 site in 1 country.

Germany1 site

Klinik für Dermatologie & Allergologie Klinikum Vest GmbH
Recklinghausen, 45657

Other trials in Germany

About this study

Conditions: Actinic Keratosis
Being tested: LEO43204 gel, 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.

LEO43204 gelDrug
Also called Ingenol Disoxate
Vehicle gelDrug

Study groups in NCT02549352
Study group	Role	What they receive
LEO 43204 gel	Experimental	Treatment once daily for 3 days Receives: Drug: LEO43204 gel
Vehicle gel	Placebo comparator	Treatment once daily for 3 days Receives: Drug: Vehicle gel

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8.
Complete clearance was defined as no clinically visible AKs in the treatment area.
The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.
Measured: At Week 8

Secondary outcomes (3)

Percentage of Participants With Partial Clearance
The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
The table shows the percentage of mean number of participants across imputations with partial clearance at Week 8.
Measured: At Week 8
Percentage of Participants With Partial Clearance
The number of clinically visible Actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1, Weeks 4, and Week 8.
Partial clearance was defined as at least 75% reduction from baseline in the number of clinically visible AKs in the treatment area.
The table shows the percentage of mean number of participants across imputations with partial clearance at Week 4.
Measured: At Week 4
Percent Reduction in AK Count in the Treatment Area Compared to Baseline
The percent reduction at Week 8 from baseline was analysed using a negative binomial regression for the AK count at Week 8 with treatment group and pooled sites as factors and baseline count as offset variable (using multiple imputations to account for missing values). The table presents adjusted mean percent reduction at Week 8 from baseline.
Measured: At Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2015Aug 2017

First posted15 Sep 2015 (estimated)
Study startNov 2015
Primary completion22 Sep 2016
Study completionAug 2017

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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 391 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02549352
Sponsor's protocol ID: LP0084-1196
Status last verified: Dec 2018
First submitted: 9 Sep 2015
Last updated: 13 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

All Actinic Keratosis trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of LEO 43204 in Field Treatment of Actinic Keratosis on Balding Scalp Including 12-month Follow-up
ClinicalTrials.gov ID: NCT02549352
Acronym / sponsor ID: LP0084-1196
Conditions: Actinic Keratosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 391 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Nov 2015
Primary completion: 22 Sep 2016 (actual)
Study completion: Aug 2017 (actual)
First posted: 15 Sep 2015 (estimated)
Results: Posted 26 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
LEO 43204 gel	Experimental	Drug: LEO43204 gelTreatment once daily for 3 days
Vehicle gel	Placebo comparator	Drug: Vehicle gelTreatment once daily for 3 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)

Subjects with 5 to 20 clinically typical, visible and discrete AKs within a treatment area of sun-damaged skin on the full balding scalp (the balding part of the scalp should be greater than 25 cm2 (4 in2) and up to approximately 250 cm2 (40 In2)
Subjects with minimum 3 clinically typical, visible and discrete AKs within a tracking area of 50 cm2 (8 In2). The tracking area must be within the treatment area

Key exclusion criteria (4 listed)

Location of the treatment area (balding scalp) within 5 cm of an incompletely healed wound or within 5 cm of a suspected BCC or SCC
Treatment with ingenol mebutate gel in the treatment area within the last 12 months
Lesions in the treatment area that have: atypical clinical appearance (e.g. hyperthrophic, hyperkeratotic or cutaneous horns) and /or, recalcitrant disease (e.g. did not respond to cryotherapy on two previous occasions)
History or evidence of skin conditions other than the trial indication that would interfere with the evaluation of the trial medication (e.g. eczema, unstable psoriasis, xeroderma pigmentosum)

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
LEO43204 gelAlso: Ingenol Disoxate	Drug	LEO 43204 gel
Vehicle gel	Drug	Vehicle gel

Primary outcome

Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)
Time frame: At Week 8
The number of clinically visible actinic keratosis lesions (AKs) identified in the treatment area was recorded at Day 1 (baseline), Weeks 4, and 8. Complete clearance was defined as no clinically visible AKs in the treatment area. The table shows the percentage of mean number of participants across imputations with complete clearance at Week 8.

3 secondary outcomes

Percentage of Participants With Partial Clearance
Time frame: At Week 8
Percentage of Participants With Partial Clearance
Time frame: At Week 4
Percent Reduction in AK Count in the Treatment Area Compared to Baseline
Time frame: At Week 8

Results and safety

Results posted to the registry on 26 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LEO 43204 0.037% Gel	209	207
Vehicle Gel	102	96

Primary outcome: Percentage of Participants With Complete Clearance of Actinic Keratosis (AK)

Time frame: At Week 8. Number (95% Confidence Interval). Unit: percentage of participants

Measure	LEO 43204 0.037% Gel n = 209	Vehicle Gel n = 101
Value	22.0 (16.4 to 27.7)	3.0 (-0.3 to 6.3)

LEO 43204 0.037% Gel vs Vehicle Gel: Ratio of clearance rates: 7.83 (95% CI 2.58 to 23.71), p <0.001, Mantel Haenszel

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment period including follow-up (from Day 1 to Week 8) and extended follow-up (from Week 8 up to Month 14). Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LEO 43204 0.037% Gel	3 of 210 (1.4%)	146 of 210 (69.5%)	Not reported
Vehicle Gel	3 of 100 (3%)	12 of 100 (12%)	Not reported
LEO 43204 0.037% Gel - Extended Follow-up	0 of 208 (0%)	5 of 208 (2.4%)	Not reported
Vehicle Gel - Extended Follow-up	0 of 92 (0%)	1 of 92 (1.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 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

Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Upper Extremities
Actinic Keratosis
RecruitingPhase 3
Study of Reformulated Levulan Kerastick Plus PDT for Actinic Keratosis on Face and Scalp
Actinic Keratosis
Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
Multiple Actinic Keratoses
RecruitingPhase 3
Basal Cell Carcinoma Chemoprevention Trial
Basal Cell Carcinoma

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.

Rolf-Markus Szeimies, Prof. Dr.med principal investigator

Klinik für Dermatologie & Allergologie Klinikum Vest GmbH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing LEO43204 gel 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 2 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 13 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 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. 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 26 Dec 2018). 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?

Percentage of Participants With Complete Clearance of Actinic Keratosis (AK) (time frame: At Week 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 NCT02549352.

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 13 Mar 2025.