HealthyPhase 1NCT01293357
A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects
A Phase 1 study testing LEO 90105 in people with Healthy, run by LEO Pharma at 1 site in Japan.
Trial summary
The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) 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
- Healthy
- What is being tested?
- LEO 90105
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Dec 2010to Dec 2010
- 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
- Healthy Japanese male subjects,
- Aged 20 to 40 years inclusive.
- Subjects without signs of skin irritation (erythema,dryness, roughness or scaling) on test sites.
- Subjects willing to follow the study procedures and complete the study Subjects having understood and signed a written informed consent.
- Subjects without abnormal in physiological test and clinical test in screening, and also judged as possible to participant the study by investigators.
Who cannot join
- Body mass Index (BMI ) (body weight (kg)/height(m)²) outside the range 18-25 kg/m2
- History of alcohol, chemical or drug abuse
- History of allergic reaction to drugs or history of skin reaction to the tape
- Any systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
- Known sensitivity to any component of any of the formulations being tested
- Known hepatic or renal disorders
Show all 17Show fewer
- Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of study start (Day 1)
- Use of systemic vitamin D analogues, vitamin D or calcium supplements within 4 weeks of study start(Day 1)
- Use of any drug (systemic or topical) within 2 weeks of study start (Day 1)
- Use of non-marketed/other investigational products one month prior to or 5 half lives (for those the half life is longer than one month) and during the trial is not permitted
- Any abnormality found at medical interview before administration of the test drug, which will affect the clinical study as judged by the investigator
- History of or active photo-induced or photoaggravated disease (abnormal response to the sun light)
- Exposure to excessive or chronic ultraviolet (UV)radiation (i.e., sunbathing, tanning salon use, phototherapy)within four weeks prior to inclusion (Day 1) or planned during the study period
- Scars, moles, sunburn, or other blemishes in the test area which would interfere with grading
- Subjects whose partner wishes to become pregnant but is unwilling to use birth control during the study
- Any condition which, in the opinion of the investigator, would place the subject at an unacceptable risk if he participated in the study
- Any disease which are contradictions for treatment of the investigation products or for which treatment with the investigation products needs to be carefully considered (Subjects with any of the following conditions present on the area(s) to be treated with study medication: viral (e.g., herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, acne rosacea, ulcers or wounds).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects A Single Centre, Randomised, Controlled, Investigator Blinded Study With Intra-individual Comparison of the Active Formulation and Its Components
The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) in healthy Japanese male subjects.
- Conditions
- Healthy
- Being tested
- LEO 90105
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEO 90105Drug
Ointment
| Study group | Role | What they receive |
|---|---|---|
| Patches | Experimental | Not described Receives: Drug: LEO 90105 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin irritation
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startDec 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Responsible party
- Sponsor
- Investigators
- Masanari Shiramoto, MD., PhD, Principal investigator, Hakata Clinica LTA Clinical Pharmacology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293357
- Sponsor's protocol ID
- MCB 0901
- Status last verified
- Mar 2015
- First submitted
- 9 Feb 2011
- 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
- A Phase 1 Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects A Single Centre, Randomised, Controlled, Investigator Blinded Study With Intra-individual Comparison of the Active Formulation and Its Components
- ClinicalTrials.gov ID
- NCT01293357
- Acronym / sponsor ID
- MCB 0901
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Quintiles, Inc.
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 10 Feb 2011 (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 objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) in healthy Japanese male subjects.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patches | Experimental | Drug: LEO 90105 |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Japanese male subjects,
- Aged 20 to 40 years inclusive.
- Subjects without signs of skin irritation (erythema,dryness, roughness or scaling) on test sites.
- Subjects willing to follow the study procedures and complete the study Subjects having understood and signed a written informed consent.
- Subjects without abnormal in physiological test and clinical test in screening, and also judged as possible to participant the study by investigators.
Key exclusion criteria (17 listed)
- Body mass Index (BMI ) (body weight (kg)/height(m)²) outside the range 18-25 kg/m2
- History of alcohol, chemical or drug abuse
- History of allergic reaction to drugs or history of skin reaction to the tape
- Any systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
- Known sensitivity to any component of any of the formulations being tested
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 90105Ointment | Drug | Patches |
Primary outcome
Skin irritation
Time frame: 5 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.
Masanari Shiramoto, MD., PhD principal investigator
Hakata Clinica LTA Clinical Pharmacology Center
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 90105 in people with Healthy, 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 17 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 (time frame: 5 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.