Psoriasis VulgarisPhase 1NCT02605057
Dermatopharmacokinetic Trial of LEO 80185 Gel
A Phase 1 study testing LEO 80185 gel and Dovobet(r) Ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Japan.
Trial summary
Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- LEO 80185 gel and Dovobet(r) Ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteJapan
- Study dates
- Nov 2015to Jul 2016
- 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed and dated informed consent form has been obtained.
- Healthy Japanese male subjects according to medical history, physical examination, ECG, vital signs and laboratory tests.
- Aged 20 to 40 years inclusive.
- Subjects with enough skin area for application of the investigational products.
Who cannot join
- Body Mass Index outside the range 18-25 kg/m²
- History or presence of alcohol or drug abuse.
- History of allergic reaction to any medications.
- Subjects with, or with a history of, systemic or cutaneous disease that could in any way confound interpretation of the trial results (e.g. atopic dermatitis, eczema, psoriasis)
- Known or suspected hypersensitivity to any component of LEO 80185 gel or Dovobet® ointment.
- Known or suspected hepatic, renal or cardiac disorders.
Show all 24Show fewer
- Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
- Subjects with any of the following skin diseases/skin abnormalities that impede the assessment of the application site (back):
- eczema/dermatitis or abnormal pigmentation
- bruises or scars
- inflammation due to sunburn
- history and/or presence of skin allergy such as atopic dermatitis
- history of drug hypersensitivity
- Signs of skin irritation/disease/disorders/symptoms or blemishes at the planned site of application (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn)
- Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibiody, HIV antigen/antibody, serological test for syphilis).
- Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
- Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
- Use of any medication (systemic or topical) within 2 weeks of Day 1.
- Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 months of Day 1.
- Current participation in any other interventional clinical trial.
- Previously randomised in this clinical trial.
- Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
- Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1.
- In the opinion of the (sub)investigator, participation in the trial is inappropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet® ointment will be applied to multiple test sites on the back of healthy Japanese male adults and the trial is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of tape stripping.
Read the detailed description
The study consists of two phases:
The pilot: The first part, known as the pilot study, will include 8 subjects and will evaluate pharmacokinetic profile of LEO 80185 gel and Dovobet® Ointment by measuring the amount of each of the active ingredients in the stratum corneum.
Pivotal: The second part, known as the pivotal study, is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The number of subjects in the pivotal study and the number of application sites for study medications will be based on the results of the pilot study.
The number of subjects included in the trial and design of trial is in line with previous type of DPK trials in Japan and the Japanese guideline
- Conditions
- Psoriasis Vulgaris
- Being tested
- LEO 80185 gel, Dovobet(r) Ointment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 80185 gelDrug
Dovobet(r) OintmentDrug
| Study group | Role | What they receive |
|---|---|---|
| LEO 80185 gel | Experimental | LEO 80185 gel will be allocated to 7 different test sites on each subject Receives: Drug: LEO 80185 gel |
| Dovobet Ointment | Experimental | Dovobet Ointment will be allocated to 7 different test sites on each subject Receives: Drug: Dovobet(r) Ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The amount of calcipotriol in the stratum corneum
Concentrations will be used to determine steady state
Measured: 24 hours
The amount of betamethasone dipropionate in the stratum corneum
Concentrations will be used to determine steady state
Measured: 24 hours
Secondary outcomes (1)
Safety (Number and type of adverse events)
Number and type of adverse events
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Masahiko Takeshi, MD, Principal investigator, Shinanokai Shinanozaka Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02605057
- Sponsor's protocol ID
- LP0076-1081
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2015
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
- Dermatopharmacokinetic Trial of LEO 80185 Gel
- ClinicalTrials.gov ID
- NCT02605057
- Acronym / sponsor ID
- LP0076-1081
- Conditions
- Psoriasis Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 16 Nov 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.
Given that LEO 80185 gel takes effect in the upper layer of the skin, it is important to compare and examine the amount of the drug in the upper layer of the skin with that of Dovobet® Ointment. Therefore, a dermatopharmacokinetic study will be conducted in healty adult male volunteers to evaluate pharmacokinetics of LEO 80185 gel and Dovobet® Ointment in the stratum corneum. In this trial, a single application of LEO 80185 gel and Dovobet® ointment will be applied to multiple test sites on the back of healthy Japanese male adults and the trial is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The amount of calcipotriol and betamethasone dipropionate in the stratum corneum will be assessed by use of tape stripping.
Detailed description
The study consists of two phases:
The pilot: The first part, known as the pilot study, will include 8 subjects and will evaluate pharmacokinetic profile of LEO 80185 gel and Dovobet® Ointment by measuring the amount of each of the active ingredients in the stratum corneum.
Pivotal: The second part, known as the pivotal study, is designed to compare the amount of each of the active ingredients at steady state or close-to-steady state between LEO 80185 gel and Dovobet® Ointment. The number of subjects in the pivotal study and the number of application sites for study medications will be based on the results of the pilot study.
The number of subjects included in the trial and design of trial is in line with previous type of DPK trials in Japan and the Japanese guideline
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEO 80185 gel | Experimental | Drug: LEO 80185 gelLEO 80185 gel will be allocated to 7 different test sites on each subject |
| Dovobet Ointment | Experimental | Drug: Dovobet(r) OintmentDovobet Ointment will be allocated to 7 different test sites on each subject |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Signed and dated informed consent form has been obtained.
- Healthy Japanese male subjects according to medical history, physical examination, ECG, vital signs and laboratory tests.
- Aged 20 to 40 years inclusive.
- Subjects with enough skin area for application of the investigational products.
Key exclusion criteria (24 listed)
- Body Mass Index outside the range 18-25 kg/m²
- History or presence of alcohol or drug abuse.
- History of allergic reaction to any medications.
- Subjects with, or with a history of, systemic or cutaneous disease that could in any way confound interpretation of the trial results (e.g. atopic dermatitis, eczema, psoriasis)
- Known or suspected hypersensitivity to any component of LEO 80185 gel or Dovobet® ointment.
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 80185 gel | Drug | LEO 80185 gel |
| Dovobet(r) Ointment | Drug | Dovobet Ointment |
Primary outcome
The amount of calcipotriol in the stratum corneum
Time frame: 24 hours
Concentrations will be used to determine steady state
The amount of betamethasone dipropionate in the stratum corneum
Time frame: 24 hours
Concentrations will be used to determine steady state
1 secondary outcome
Safety (Number and type of adverse events)
Time frame: 24 hours
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.
- 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.
Masahiko Takeshi, MD principal investigator
Shinanokai Shinanozaka Clinic
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 80185 gel and Dovobet(r) Ointment in people with Psoriasis Vulgaris, run by LEO Pharma at 1 site in Japan.
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 24 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 Japan. 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?
The amount of calcipotriol in the stratum corneum (time frame: 24 hours). 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?
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.