Actinic KeratosisPhase 1/2NCT02120456

Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis

A Phase 1/2 study testing LEO 43204 in people with Actinic Keratosis, run by LEO Pharma at 21 sites in 2 countries.

Completed

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

Trial summary

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle 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?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: 21 sitesin 2 countries
Study dates: May 2014to May 2015
Phase: Phase 1/2
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

Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

Who cannot join

Location of the treatment area
within 5 cm of an incompletely healed wound
within 5 cm of a suspected basal cell carcinoma (BCC) or squamous cell carcinoma (SCC)
Prior treatment with ingenol mebutate gel on the treatment area
Lesions in the treatment areas that have:
atypical clinical appearance (e.g., hypertrophic, hyperkeratotic or cutaneous horns) and/or
recalcitrant disease (e.g., did not respond to cryotherapy on two previous occasions)

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

United States13 sites

Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Dermatology Associates and Research
Coral Gables, Florida, 33134
Deaconess Clinic, Inc.
Evansville, Indiana, 47713
Hudson Dermatology, LLC
Evansville, Indiana, 47714
Torrance Clinical Research Institute Inc.
Lomita, California, 90717
Leavitt Medical Associates of Florida
Ormond Beach, Florida, 32174
Pflugerville Dermatology Clinical Research Center, Inc.
Pflugerville, Texas, 78660
Omni Dermatology
Phoenix, Arizona, 85018
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Indiana Clinical Trials Center
Plainfield, Indiana, 46168
DermAssociates, PC
Rockville, Maryland, 20850
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121
The Dermatology Group, P.C.
Verona, New Jersey, 07044

Other trials in United States

Canada8 sites

UltraNova Skincare
Barrie, Ontario, L4M 6L2
Kirk Barber Research
Calgary, Alberta, T2G 1B1
Dermatrials Research Incorporated
Hamilton, Ontario, L8N 1V6
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
Enverus Medical
Surrey, British Columbia, V3R 6A7
Skin Care Centre
Vancouver, British Columbia, V5Z 4E8
Winnipeg Clinic Dermatology Research
Winnipeg, Manitoba, R3C 0N2

Other trials in Canada

About this study

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Conditions: Actinic Keratosis
Being tested: LEO 43204, Placebo
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
PlaceboDrug

Study groups in NCT02120456
Study group	Role	What they receive
LEO 43204	Experimental	Open-label, dose-escalation, 2-day treatment Receives: Drug: LEO 43204
LEO 43204 Dose 0.1%	Experimental	LEO 43204 dose 0.1% once daily for two consecutive days Receives: Drug: LEO 43204
LEO 43204 Dose 0.075%	Experimental	LEO 43204 dose 0.075% once daily for two days Receives: Drug: LEO 43204
Placebo	Placebo comparator	Placebo once daily for two days Receives: Drug: Placebo

What is being measured

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

Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT.
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:
- Crusting Grade 3
- Swelling Grade 4
- Erosion/Ulceration Grade 3
- Vesiculation/Pustulation Grade 3 or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT.
The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.
Measured: From Day 1 up to and including Day 8
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.
Measured: From baseline to Week 8

Secondary outcomes (2)

Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])
Complete clearance was defined as a 100% reduction from baseline in AK count.
Measured: From baseline to Week 8
Part 2: Participants With Partial Clearance of AKs (LOCF)
Partial clearance was defined as at least 75% reduction from baseline in AK count.
Measured: From baseline to Week 8

Timeline

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

May 2014May 2015

First posted22 Apr 2014 (estimated)
Study startMay 2014
Primary completionMay 2015
Study completionMay 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.
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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02120456
Sponsor's protocol ID: LP0084-1015
Status last verified: Nov 2018
First submitted: 18 Apr 2014
Last updated: 6 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 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Escalating Doses of LEO 43204 Applied Once Daily for Two Consecutive Days on Approximately 250 cm2 on Trunk and Extremities in Subjects With Actinic Keratosis
ClinicalTrials.gov ID: NCT02120456
Acronym / sponsor ID: LP0084-1015
Conditions: Actinic Keratosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: May 2014
Primary completion: May 2015 (actual)
Study completion: May 2015 (actual)
First posted: 22 Apr 2014 (estimated)
Results: Posted 4 Jan 2019

Clinical summary

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

Part 1: To identify Maximum Tolerated Dose (MTD) levels of LEO 43204 after once daily treatment for two consecutive days

Part 2: To evaluate the efficacy of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
LEO 43204	Experimental	Drug: LEO 43204Open-label, dose-escalation, 2-day treatment
LEO 43204 Dose 0.1%	Experimental	Drug: LEO 43204LEO 43204 dose 0.1% once daily for two consecutive days
LEO 43204 Dose 0.075%	Experimental	Drug: LEO 43204LEO 43204 dose 0.075% once daily for two days
Placebo	Placebo comparator	Drug: PlaceboPlacebo once daily for two 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)

Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the arm
Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the extremities or trunk

Key exclusion criteria (7 listed)

Location of the treatment area
Prior treatment with ingenol mebutate gel on the treatment area
Lesions in the treatment areas that have:

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 43204	Drug	LEO 43204, LEO 43204 Dose 0.075%, LEO 43204 Dose 0.1%
Placebo	Drug	Placebo

Primary outcome

Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
Time frame: From Day 1 up to and including Day 8
The number participants experiencing a DLT was used to identify the maximum tolerated dose(MTD) levels of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level at which less than 4 out of 12 participants experienced a DLT. 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: * Crusting Grade 3 * Swelling Grade 4 * Erosion/Ulceration Grade 3 * Vesiculation/Pustulation Grade 3 or other clinically relevant signs or symptoms observed, which the Investigator judged to be counted as a DLT. The LSRs consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category was given a numeric grade of severity from 0-4. Grade 0 being no presence and Grade 4 being the highest grade of severity.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count
Time frame: From baseline to Week 8
Percent reduction from baseline in clinically visible actinic keratosis lesions (AKs) identified in the treatment area.

2 secondary outcomes

Part 2: Participants With Complete Clearance of AKs (Last Observation Carried Forward [LOCF])
Time frame: From baseline to Week 8
Part 2: Participants With Partial Clearance of AKs (LOCF)
Time frame: From baseline to Week 8

Results and safety

Results posted to the registry on 4 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1: LEO 43204 Gel 0.018%	12	12
Part 1: LEO 43204 Gel 0.025%	12	12
Part 1: LEO 43204 Gel 0.037%	12	12
Part 1: LEO 43204 Gel 0.05%	12	12
Part 1: LEO 43204 Gel 0.075%	12	12
Part 1: LEO 43204 Gel 0.1%	9	9
Part 2: LEO 43204 Vehicle Gel	0	0
Part 2: LEO 43204 Gel 0.075%	0	0
Part 2: LEO 43204 Gel 0.1%	0	0

Primary outcome: Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)

Time frame: From Day 1 up to and including Day 8. Count of participants. Unit: Participants

Measure	Part 1: LEO 43204 Gel 0.018% n = 12	Part 1: LEO 43204 Gel 0.025% n = 12	Part 1: LEO 43204 Gel 0.037% n = 12	Part 1: LEO 43204 Gel 0.05% n = 12	Part 1: LEO 43204 Gel 0.075% n = 12	Part 1: LEO 43204 Gel 0.1% n = 9
Yes	0	0	2	1	1	0
No	12	12	10	11	11	9

Primary outcome: Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Count

Time frame: From baseline to Week 8. Mean (95% Confidence Interval). Unit: percentage of reduction

Measure	Part 2: LEO 43204 Vehicle Gel n = 32	Part 2: LEO 43204 Gel 0.075% n = 60	Part 2: LEO 43204 Gel 0.1% n = 63
Value	32.7 (17.9 to 44.8)	70.0 (64.1 to 74.9)	62.2 (55.5 to 67.8)

Part 2: LEO 43204 Vehicle Gel vs Part 2: LEO 43204 Gel 0.075%: Rate ratio: 0.45 (95% CI 0.34 to 0.58), p <0.001, Negative binominal regression
Part 2: LEO 43204 Vehicle Gel vs Part 2: LEO 43204 Gel 0.1%: Rate ratio: 0.56 (95% CI 0.44 to 0.73), p <0.001, Negative binominal regression
Part 2: LEO 43204 Gel 0.075% vs Part 2: LEO 43204 Gel 0.1%: Rate ratio: 1.26 (95% CI 0.99 to 1.60), p = 0.058, Negative binominal regression

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Part 1: From Day 1 to Week 2 Part 2: From Day 1 to Week 8. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: LEO 43204 Gel 0.018%	0 of 12 (0%)	3 of 12 (25%)	Not reported
Part 1: LEO 43204 Gel 0.025%	0 of 12 (0%)	3 of 12 (25%)	Not reported
Part 1: LEO 43204 Gel 0.037%	0 of 12 (0%)	5 of 12 (41.7%)	Not reported
Part 1: LEO 43204 Gel 0.05%	0 of 12 (0%)	9 of 12 (75%)	Not reported
Part 1: LEO 43204 Gel 0.075%	0 of 12 (0%)	10 of 12 (83.3%)	Not reported
Part 1: LEO 43204 Gel 0.1%	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
Part 2: LEO 43204 Vehicle Gel	0 of 32 (0%)	6 of 32 (18.8%)	Not reported
Part 2: LEO 43204 Gel 0.075%	1 of 60 (1.7%)	36 of 60 (60%)	Not reported
Part 2: LEO 43204 Gel 0.1%	2 of 63 (3.2%)	39 of 63 (61.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 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.

Gary Goldenberg, MD principal investigator

Mount Sinai School of Medicine, Dermatology Faculty

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing LEO 43204 in people with Actinic Keratosis, run by LEO Pharma at 21 sites in 2 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 2 inclusion and 7 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 6 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 21 sites in United States, Canada. 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 combined 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.

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 4 Jan 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?

Part 1: Participants Experiencing Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs) (time frame: From Day 1 up to and including Day 8). The study lists 2 primary outcomes in all. 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 NCT02120456.

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 6 Mar 2025.