Skin and Connective Tissue DiseasesPhase 1NCT02379793
Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects
A Phase 1 study of Skin and Connective Tissue Diseases, run by LEO Pharma at 1 site in Japan.
Trial summary
The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects. 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
- Skin and Connective Tissue Diseases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2015to Apr 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 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Signed informed consent has been obtained.
- Healthy Japanese male subjects.
- Aged 20 to 40 years inclusive.
- Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
- Subjects without a significant abnormality, as judged by the (sub)investigator
Who cannot join
- Body Mass Index outside the range 18-25 kg/m²
- History of alcohol or drug abuse.
- History of allergic reaction to any medications.
- Any disease that could in any way confound assessment of the test sites.
- Known or suspected hypersensitivity to any component of LEO 80185 gel.
- Known or suspected hepatic, renal or cardiac disorders.
Show all 18Show 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 suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, 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 weeks or 5 half-lives of Day 1, whichever is longest.
- Current participation in any other interventional clinical trial.
- Previously enrolled 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.
- Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4).
- In the opinion of the (sub)investigator, participation in the trial is inappropriate.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Medical Co. LTA HAKATA Clinic
Random Square 5F, 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
About this study
Official title: Skin Irritation Test of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.
- Conditions
- Skin and Connective Tissue Diseases
- Being tested
- LEO 80185 gel, vehicle, liquid paraffin
- Keywords
- LEO 80185 gel, calcipotriol, betamethasone
- Medical subject headings
- Skin and Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 80185 gel, vehicle, liquid paraffinDrug
Each subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject.
| Study group | Role | What they receive |
|---|---|---|
| LEO 80185 gel, vehicle, liquid paraffin | Experimental | Each subject has all 3 treatments applied topically at the same time. However, the location on which the treatments are applied is randomised in an investigator blinded manner. Receives: Drug: LEO 80185 gel, vehicle, liquid paraffin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin irritation measured as -, +/-, +, ++, +++, ++++
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin and Connective Tissue DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379793
- Sponsor's protocol ID
- LP0076-1080
- Status last verified
- Feb 2015
- First submitted
- 26 Feb 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
- Skin Irritation Test of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT02379793
- Acronym / sponsor ID
- LP0076-1080
- Conditions
- Skin and Connective Tissue Diseases
- Keywords
- LEO 80185 gel, calcipotriol, betamethasone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 5 Mar 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.
The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LEO 80185 gel, vehicle, liquid paraffin | Experimental | Drug: LEO 80185 gel, vehicle, liquid paraffinEach subject has all 3 treatments applied topically at the same time. However, the location on which the treatments are applied is randomised in an investigator blinded manner. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Signed informed consent has been obtained.
- Healthy Japanese male subjects.
- Aged 20 to 40 years inclusive.
- Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
- Subjects without a significant abnormality, as judged by the (sub)investigator
Key exclusion criteria (18 listed)
- Body Mass Index outside the range 18-25 kg/m²
- History of alcohol or drug abuse.
- History of allergic reaction to any medications.
- Any disease that could in any way confound assessment of the test sites.
- Known or suspected hypersensitivity to any component of LEO 80185 gel.
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, vehicle, liquid paraffinEach subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject. | Drug | LEO 80185 gel, vehicle, liquid paraffin |
Primary outcome
Skin irritation measured as -, +/-, +, ++, +++, ++++
Time frame: 4 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.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 of Skin and Connective Tissue Diseases, 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 5 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 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?
Skin irritation measured as -, +/-, +, ++, +++, ++++ (time frame: 4 days). 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.