Actinic KeratosisPhase 1/2NCT01922050

A Study of Increasing Strengths, Safety and Efficacy of Two Formulas of LEO 43204 on the Face or the Chest in Patients With Actinic Keratosis

A Phase 1/2 study testing LEO 43204 Formulation 1, LEO 43204 Formulation 2 and LEO 43204 Formulation 1 Dose X in people with Actinic Keratosis, run by LEO Pharma at 25 sites in 2 countries.

Completed

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

Official record

Search all trials

Trial summary

Part 1: To identify Maximum Tolerated Dose (MTD) levels of two formulations of LEO 43204 after once daily treatment for two consecutive days Part 2: To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations 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 Formulation 1, LEO 43204 Formulation 2 and LEO 43204 Formulation 1 Dose X
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 320 participants
Where: 25 sitesin 2 countries
Study dates: Oct 2013to Nov 2014
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

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.
Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face
Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest
Subject at least 18 years of age.
Female subjects must be of either:
Non-childbearing potential, i.e., have a confirmed clinical history of sterility (e.g., the subject is without a uterus or have tubal ligation), or,
Childbearing potential, provided there is a confirmed negative urine pregnancy test prior to trial treatment.
Female subjects of childbearing potential must use effective contraception throughout the study.

Who cannot join

Location of the treatment area within 5 cm (2 inches) of:
an incompletely healed wound,
a suspected basal or squamous cell carcinoma.
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

Show all 18Show fewer

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, Rosacea), at the investigator's discretion.
Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.
Any other disease or medical condition such as history or presence of cancer, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, or neurological disease or disorder, that, in the opinion of the investigator, makes the subject unsuitable to participate in the trial.
Any abnormal laboratory or ECG findings that are clinically significant and would impact the safety of the subjects or the interpretation of the study results, as determined by the investigator.
Anticipated need for hospitalisation or out-patient surgery during the first 15 days after the first trial medication application. Note that cosmetic/therapeutic procedures are not excluded if they fall outside of the criteria detailed in Prohibited Therapies or Medications.
Known sensitivity or allergy to any of the ingredients in the LEO 43204.
Presence of acute sunburn within the treatment areas.
Current enrolment or participation in an investigational clinical trial within 30 days of entry into this trial.
Subjects previously randomised in the trial (Part 1 or 2).
Female subjects who are breastfeeding.
In the opinion of the investigator, the subject is unlikely to comply with the Clinical Study Protocol (e.g., alcoholism, drug dependency or psychotic state).

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States13 sites

Great Lakes Research Group, Inc.
Bay City, Michigan, 48706
Research Institute of Deaconess Clinic
Evansville, Indiana, 47713
Hudson Dermatology, LLC
Evansville, Indiana, 47714
Torrance Clinical Research Institute Inc.
Lomita, California, 90717
Mount Sinai School of Medicine
New York, New York, 10029
Leavitt Medical Associates of Florida
Ormond Beach, Florida, 32174
Omni Dermatology
Phoenix, Arizona, 85018
DermAssociates, PC
Rockville, Maryland, 20850
Clinical Trials of Texas, Inc.
San Antonio, Texas, 78229
Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.
San Diego, California, 92121
Clinical Research Center, Morsani Center for Advanced Healthcare
Tampa, Florida, 33612
The Dermatology Group, P.C.
Verona, New Jersey, 07044
Henry Ford Medical Center, Dept. of Dermatology
West Bloomfield, Michigan, 48322

Other trials in United States

Canada12 sites

Ultranova Skincare
Barrie, Ontario, L4M 6L2
Co-Medica Research Network Inc.
Courtice, Ontario, L1E 3C3
Stratica Medical Inc.
Edmonton, Alberta, T5K 1X3
Dermatrials Research Incorporated
Hamilton, Ontario, L8N 1V6
The Guenther Dermatology Research Centre
London, Ontario, N6A 3H7
Lynderm Research Inc.
Markham, Ontario, L3P 1A8
Durondel C.P. Inc./Dermatology Clinic
Moncton, New Brunswick, E1C 8X3
SKiN Centre for Dermatology
Peterborough, Ontario, K9J 1Z2
Centre de Recherche Dermatologique du Quebec Metropolitain
Québec, Quebec, G1V 4X7
Guildford Dermatology Specialists
Surrey, British Columbia, V3R 6A7
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4
XLR8 Medical Research
Windsor, Ontario, N8W 1E6

Other trials in Canada

About this study

Official title: Safety and Efficacy of Escalating Doses of Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis

Part 1:

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

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Conditions: Actinic Keratosis
Being tested: LEO 43204 Formulation 1, LEO 43204 Formulation 2, LEO 43204 Formulation 1 Dose X, LEO 43204 Formulation 1 Dose Y, LEO 43204 Formulation 2 Dose XX
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 43204 Formulation 1Drug
LEO 43204 Formulation 2Drug
LEO 43204 Formulation 1 Dose XDrug
LEO 43204 Formulation 1 Dose YDrug
LEO 43204 Formulation 2 Dose XXDrug
LEO 43204 Formulation 2 Dose YYDrug
Placebo Formulation 1Drug
Placebo Formulation 2Drug

Study groups in NCT01922050
Study group	Role	What they receive
Part 1: LEO 43204 Formulation 1	Experimental	Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment Receives: Drug: LEO 43204 Formulation 1
Part 1: LEO 43204 Formulation 2	Experimental	Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment Receives: Drug: LEO 43204 Formulation 2
Part 2: LEO 43204 Formulation 1 Dose X	Experimental	Double-Blind, Once-Daily, 2-Day Treatment Receives: Drug: LEO 43204 Formulation 1 Dose X
Part 2: LEO 43204 Formulation 1 Dose Y	Experimental	Double-Blind, Once-Daily, 2-Day Treatment Receives: Drug: LEO 43204 Formulation 1 Dose Y
Part 2: LEO 43204 Formulation 2 Dose XX	Experimental	Double-Blind, Once-Daily, 2-Day Treatment Receives: Drug: LEO 43204 Formulation 2 Dose XX
Part 2: LEO 43204 Formulation 2 Dose YY	Experimental	Double-Blind, Once-Daily, 2-Day Treatment Receives: Drug: LEO 43204 Formulation 2 Dose YY
Part 2: Placebo Formulation 1	Placebo comparator	Double-Blind, Once-Daily, 2-Day Treatment Receives: Drug: Placebo Formulation 1
Part 2: Placebo Formulation 2	Placebo comparator	Double-Blind, Once-Daily, 2-Day Treatment Receives: Drug: Placebo Formulation 2

What is being measured

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

Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT
DLT was defined as one or more of the following 3 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
The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 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) Counts (Multiple Imputation)
Measured: At Week 8

Secondary outcomes (2)

Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)
Complete clearance was defined as a 100% reduction from baseline in AK count. For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with complete clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with complete clearance in observed cases.
Measured: At Week 8
Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)
Partial clearance was defined as at least 75% reduction from baseline in AK count.
For treatment groups Vehicle, 0.006 and 0.012 the table shows the percentage of mean number of participants across imputations with partial clearance. For treatment group 0.018 the table shows the percentage of mean number of participants with partial clearance in observed cases.
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.

Oct 2013Nov 2014

First posted14 Aug 2013 (estimated)
Study startOct 2013
Primary completionNov 2014
Study completionNov 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.
Publications (1)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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 320 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01922050
Sponsor's protocol ID: LP0084-1013
Status last verified: Feb 2019
First submitted: 12 Aug 2013
Last updated: 6 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

Bourcier M, Stein Gold L, Guenther L, Andreassen CM, Selmer J, Goldenberg G. A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm2 on the chest. J Dermatolog Treat. 2017 Nov;28(7):652-658. doi: 10.1080/09546634.2017.1303568. Epub 2017 Apr 4.
PubMed 28264612

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
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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
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Active, not recruitingPhase 3
A Pilot Clinical Trial Comparing Topical Fluorouracil to Fluorouracil Plus Calcipotriene Field Treatments in Patients With Multiple Actinic Keratoses
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RecruitingPhase 3
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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 Two LEO 43204 Formulations Applied Once Daily for Two Consecutive Days on Full Face or Approximately 250 cm2 (40 in2) on the Chest in Subjects With Actinic Keratosis
ClinicalTrials.gov ID: NCT01922050
Acronym / sponsor ID: LP0084-1013
Conditions: Actinic Keratosis
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 320 participants (actual)
Lead sponsor: LEO PharmaIndustry (pharma, biotech, devices)
Study start: Oct 2013
Primary completion: Nov 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 14 Aug 2013 (estimated)
Results: Posted 27 Feb 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 two formulations of LEO 43204 after once daily treatment for two consecutive days

Part 2:

To evaluate efficacy of two formulations of LEO 43204 in two doses after once daily treatment for two consecutive days compared to vehicle formulations

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Part 1: LEO 43204 Formulation 1	Experimental	Drug: LEO 43204 Formulation 1Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
Part 1: LEO 43204 Formulation 2	Experimental	Drug: LEO 43204 Formulation 2Open-Label, Dose-Escalation, Once-Daily, 2-Day Treatment
Part 2: LEO 43204 Formulation 1 Dose X	Experimental	Drug: LEO 43204 Formulation 1 Dose XDouble-Blind, Once-Daily, 2-Day Treatment
Part 2: LEO 43204 Formulation 1 Dose Y	Experimental	Drug: LEO 43204 Formulation 1 Dose YDouble-Blind, Once-Daily, 2-Day Treatment
Part 2: LEO 43204 Formulation 2 Dose XX	Experimental	Drug: LEO 43204 Formulation 2 Dose XXDouble-Blind, Once-Daily, 2-Day Treatment
Part 2: LEO 43204 Formulation 2 Dose YY	Experimental	Drug: LEO 43204 Formulation 2 Dose YYDouble-Blind, Once-Daily, 2-Day Treatment
Part 2: Placebo Formulation 1	Placebo comparator	Drug: Placebo Formulation 1Double-Blind, Once-Daily, 2-Day Treatment
Part 2: Placebo Formulation 2	Placebo comparator	Drug: Placebo Formulation 2Double-Blind, Once-Daily, 2-Day Treatment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 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.
Part 1: Subjects with 5 to 20 clinically typical, visible and discrete AKs on the face
Part 2: Subjects with 5 to 20 clinically typical, visible and discrete AKs on either the face or within a contiguous area of approximately 250 cm2 (40 in2) on the chest
Subject at least 18 years of age.
Female subjects must be of either:

Key exclusion criteria (18 listed)

Location of the treatment area within 5 cm (2 inches) of:
Prior treatment with ingenol mebutate gel on the treatment area.
Lesions in the treatment areas that have:
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, Rosacea), at the investigator's discretion.
Use of cosmetic or therapeutic products and procedures which could interfere with the assessments of the treatment areas.

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 Formulation 1	Drug	Part 1: LEO 43204 Formulation 1
LEO 43204 Formulation 2	Drug	Part 1: LEO 43204 Formulation 2
LEO 43204 Formulation 1 Dose X	Drug	Part 2: LEO 43204 Formulation 1 Dose X
LEO 43204 Formulation 1 Dose Y	Drug	Part 2: LEO 43204 Formulation 1 Dose Y
LEO 43204 Formulation 2 Dose XX	Drug	Part 2: LEO 43204 Formulation 2 Dose XX
LEO 43204 Formulation 2 Dose YY	Drug	Part 2: LEO 43204 Formulation 2 Dose YY
Placebo Formulation 1	Drug	Part 2: Placebo Formulation 1
Placebo Formulation 2	Drug	Part 2: Placebo Formulation 2

Primary outcome

Part 1: Number of Participants Experiencing a Dose Limiting Toxicity (DLT) Based on Local Skin Responses (LSRs)
Time frame: From Day 1 up to and including Day 8
The number of participants experiencing DLTs are tabulated by treatment group. This was used to identify the maximum tolerated dose (MTD) of LEO 43204 after once daily treatment for 2 consecutive days.The MTD was defined as the highest dose level with less than 4 out of 12 participants(cohorts 1 to 4) or less than 6 out of 18 participants(cohorts 5 and 6) experiencing a DLT DLT was defined as one or more of the following 3 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 The Local Skin Responses consists of the following 6 categories: Erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, erosion/ulceration. Each individual LSR category are given a numeric grade of severity from 0-4. Grade 0 being no presence and 4 being the highest grade of severity.
Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)
Time frame: At Week 8

2 secondary outcomes

Part 2: Percentage of Participants With Complete Clearance of Actinic Keratosis Lesions (AKs) (Multiple Imputation)
Time frame: At Week 8
Part 2: Percentage of Participants With Partial Clearance of AKs (Multiple Imputation)
Time frame: At Week 8

Results and safety

Results posted to the registry on 27 Feb 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 0.0015	3	3
Part 1: LEO 43204 Gel 0.003	3	3
Part 1: LEO 43204 Gel 0.006	6	6
Part 1: LEO 43204 Gel 0.012	6	6
Part 1: LEO 43204 Gel 0.018	17	17
Part 1: LEO 43204 Gel 0.025	18	18
Part 1: LEO 43204 Cream 0.0015	3	3
Part 1: LEO 43204 Cream 0.003	3	3
Part 1: LEO 43204 Cream 0.006	6	6
Part 1: LEO 43204 Cream 0.012	12	12
Part 2: LEO 43204 Gel 0.006	0	0
Part 2: LEO 43204 Gel 0.012	0	0
Part 2: LEO 43204 Gel 0.018	0	0
Part 2: LEO 43204 Gel Vehicle	0	0

Primary outcome: Part 1: Number of Participants Experiencing a 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: Cohort 1: LEO 43204 Gel 0.0015 n = 3	Part 1: Cohort 2: LEO 43204 Gel 0.003 n = 3	Part 1: Cohort 3: LEO 43204 Gel 0.006 n = 6	Part 1: Cohort 4: LEO 43204 Gel 0.012 n = 6	Part 1: Cohort 5: LEO 43204 Gel 0.018 n = 17	Part 1: Cohort 6: LEO 43204 Gel 0.025 n = 18	Part 1: Cohort 1: LEO 43204 Cream 0.0015 n = 3	Part 1: Cohort 2: LEO 43204 Cream 0.003 n = 3	Part 1: Cohort 3: LEO 43204 Cream 0.006 n = 6	Part 1: Cohort 4: LEO 43204 Cream 0.012 n = 12
No	3	3	6	6	17	12	3	3	6	9
Yes	0	0	0	0	0	6	0	0	0	3

Primary outcome: Part 2: Percent Reduction From Baseline in Actinic Keratosis (AK) Counts (Multiple Imputation)

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

Measure	Part 2: LEO 43204 Gel Vehicle n = 58	Part 2: LEO 43204 Gel 0.006 n = 62	Part 2: LEO 43204 Gel 0.012 n = 60	Part 2: LEO 43204 Gel 0.018 n = 62
Value	42.3 (30.5 to 52.1)	69.7 (63.1 to 75.1)	73.4 (67.1 to 78.5)	79.0 (74.0 to 83.0)

Part 2: LEO 43204 Gel Vehicle vs Part 2: LEO 43204 Gel 0.006: Rate ratio: 0.53 (95% CI 0.40 to 0.69), p <0.001, Negative binominal regression
Part 2: LEO 43204 Gel Vehicle vs Part 2: LEO 43204 Gel 0.012: Rate ratio: 0.46 (95% CI 0.35 to 0.61), p <0.001, Negative binominal regression
Part 2: LEO 43204 Gel Vehicle vs Part 2: LEO 43204 Gel 0.018: Rate ratio: 0.36 (95% CI 0.28 to 0.48), p <0.001, Negative binominal regression

Population analysed: The analysis was based on the Full Analysis Set, which was defined as all randomized participants who applied investigation product. One participant from the LEO 43204 gel vehicle arm did not apply investigation product, and thus was excluded from the efficacy analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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 0.0015	0 of 3 (0%)	3 of 3 (100%)	Not reported
Part 1: LEO 43204 Gel 0.003	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Part 1: LEO 43204 Gel 0.006	1 of 6 (16.7%)	5 of 6 (83.3%)	Not reported
Part 1: LEO 43204 Gel 0.012	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
Part 1: LEO 43204 Gel 0.018	1 of 17 (5.9%)	10 of 17 (58.8%)	Not reported
Part 1: LEO 43204 Gel 0.025	0 of 18 (0%)	11 of 18 (61.1%)	Not reported
Part 1: LEO 43204 Cream 0.0015	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Part 1: LEO 43204 Cream 0.003	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
Part 1: LEO 43204 Cream 0.006	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Part 1: LEO 43204 Cream 0.012	0 of 12 (0%)	8 of 12 (66.7%)	Not reported
Part 2: LEO 43204 Gel Vehicle	0 of 58 (0%)	11 of 58 (19%)	Not reported
Part 2: LEO 43204 Gel 0.006	5 of 62 (8.1%)	38 of 62 (61.3%)	Not reported
Part 2: LEO 43204 Gel 0.012	2 of 60 (3.3%)	40 of 60 (66.7%)	Not reported
Part 2: LEO 43204 Gel 0.018	0 of 62 (0%)	47 of 62 (75.8%)	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.
Derived from this study: PubMed 28264612Bourcier M, Stein Gold L, Guenther L, Andreassen CM, Selmer J, Goldenberg G. A dose-finding trial with a novel ingenol derivative (ingenol disoxate: LEO 43204) for field treatment of actinic keratosis on full face or 250 cm2 on the chest. J Dermatolog Treat. 2017 Nov;28(7):652-658. doi: 10.1080/09546634.2017.1303568. Epub 2017 Apr 4.
Individual participant dataSharing planned: No

Related trials for Actinic Keratosis

Active, not recruitingPhase 1
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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.

Gary Goldenberg, MD principal investigator

Mount Sinai School of Medicine, Dermatology Faculty

25 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 Formulation 1, LEO 43204 Formulation 2 and LEO 43204 Formulation 1 Dose X in people with Actinic Keratosis, run by LEO Pharma at 25 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 8 inclusion and 18 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 25 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 27 Feb 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: Number of Participants Experiencing a 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 NCT01922050, 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 6 Mar 2025.