Actinic KeratosisPhase 1NCT02424305
Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions
A Phase 1 study testing LEO 43204 gel 0.018%, LEO 43204 gel 0.1% and LEO 43204 gel 0.037% in people with Actinic Keratosis, run by LEO Pharma at 1 site in United States.
Trial summary
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face… 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 gel 0.018%, LEO 43204 gel 0.1% and LEO 43204 gel 0.037%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jul 2015
- Phase
- Phase 1
- 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
- Subjects with 15 or more clinically typical, visible and discrete AKs on either:
- Full face (corresponding to a treatment area of at least 250 cm2). If subjects have a beard they must shave no later than the day before the first drug application.
- A contiguous area of approximately 250 cm2 on the arm between wrist and shoulder.
- Balding scalp (corresponding to a treatment area of approximately 250 cm2). Subjects with sparse hair on the scalp can be enrolled as long as LSR and AK assessments are not compromised.
- Subject at least 18 years of age.
- Female subjects of childbearing potential* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
- Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
Who cannot join
- Location of the treatment area (full face, full balding scalp, chest, trunk or extremities)
- within 5 cm of an incompletely healed wound.
- 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.
- 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
Pflugerville Dermatology Clinical Research
Pflugerville, Texas, 7866
About this study
This is an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.
- Conditions
- Actinic Keratosis
- Being tested
- LEO 43204 gel 0.018%, LEO 43204 gel 0.1%, LEO 43204 gel 0.037%
- 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 gel 0.018%Drug
LEO 43204 gel 0.1%Drug
LEO 43204 gel 0.037%Drug
| Study group | Role | What they receive |
|---|---|---|
| face: LEO 43204 gel 0.018% | Experimental | 3 days treatment (once daily) on face: LEO 43204 gel 0.018% Receives: Drug: LEO 43204 gel 0.018% |
| arm: LEO 43204 gel 0.1% | Experimental | 3 days treatment (once daily) on arm: LEO 43204 gel 0.1% Receives: Drug: LEO 43204 gel 0.1% |
| scalp: LEO 43204 gel 0.037% | Experimental | 3 days treatment (once daily) on scalp: LEO 43204 gel 0.037% Receives: Drug: LEO 43204 gel 0.037% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of LEO 43204.
Measured: Once daily for 3 days
Peak Plasma Concentration (Cmax) of LEO 43204.
Measured: Once daily for 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2015
- Study completionJul 2015
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 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edward Lain, MD, Principal investigator, Pflugerville Dermatology Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424305
- Sponsor's protocol ID
- LP0084-1077
- Status last verified
- May 2017
- First submitted
- 14 Apr 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lain E, Skov T, Hall A. Pharmacokinetics and Safety of Ingenol Disoxate Gel Administered Under Maximum-Use Conditions to Patients With Actinic Keratosis. Clin Drug Investig. 2018 Mar;38(3):249-257. doi: 10.1007/s40261-017-0608-y.
PubMed 29204958
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
- Pharmacokinetics of LEO 43204 Gel in Actinic Keratosis Administered Under Maximal Use Conditions
- ClinicalTrials.gov ID
- NCT02424305
- Acronym / sponsor ID
- LP0084-1077
- Conditions
- Actinic Keratosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 23 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 an open-label, uncontrolled, non-randomised multi-centre trial in which 3 parallel groups will be enrolled. The trial includes three active treatment groups. To be eligible for inclusion in this trial, subjects must have at least 15 clinically typical, visible, and discrete actinic keratosis (AKs) on the face, scalp or on the arm within a contiguous area of approximately 250 cm2 of sun-damaged skin.
There will be 3 treatment groups: (1) once daily application of LEO43204 gel 0.018% on the full face for three consecutive days, (2) once daily application of LEO43204 gel 0.1% on the arm on a treatment area of approximately 250 cm2 for three consecutive days and , (3) once daily application of LEO43204 gel 0.037 % on the scalp for three consecutive days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| face: LEO 43204 gel 0.018% | Experimental | Drug: LEO 43204 gel 0.018%3 days treatment (once daily) on face: LEO 43204 gel 0.018% |
| arm: LEO 43204 gel 0.1% | Experimental | Drug: LEO 43204 gel 0.1%3 days treatment (once daily) on arm: LEO 43204 gel 0.1% |
| scalp: LEO 43204 gel 0.037% | Experimental | Drug: LEO 43204 gel 0.037%3 days treatment (once daily) on scalp: LEO 43204 gel 0.037% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with 15 or more clinically typical, visible and discrete AKs on either:
- Subject at least 18 years of age.
- Female subjects of childbearing potential* must be confirmed not pregnant by a negative urine pregnancy test prior to trial treatment.
- Female subjects of childbearing potential must be willing to use effective contraception at trial entry and until completion.
Key exclusion criteria (5 listed)
- Location of the treatment area (full face, full balding scalp, chest, trunk or extremities)
- Previously assigned treatment in this clinical trial or previously participated in a clinical trial in the LEO 43204 programme.
- 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 43204 gel 0.018% | Drug | face: LEO 43204 gel 0.018% |
| LEO 43204 gel 0.1% | Drug | arm: LEO 43204 gel 0.1% |
| LEO 43204 gel 0.037% | Drug | scalp: LEO 43204 gel 0.037% |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of LEO 43204.
Time frame: Once daily for 3 days
Peak Plasma Concentration (Cmax) of LEO 43204.
Time frame: Once daily for 3 days
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 29204958Lain E, Skov T, Hall A. Pharmacokinetics and Safety of Ingenol Disoxate Gel Administered Under Maximum-Use Conditions to Patients With Actinic Keratosis. Clin Drug Investig. 2018 Mar;38(3):249-257. doi: 10.1007/s40261-017-0608-y.
- 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.
Edward Lain, MD principal investigator
Pflugerville Dermatology Clinical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LEO 43204 gel 0.018%, LEO 43204 gel 0.1% and LEO 43204 gel 0.037% 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 7 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 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 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.
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?
Area under the plasma concentration versus time curve (AUC) of LEO 43204. (time frame: Once daily for 3 days). 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 NCT02424305, 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.