CClinicalTrials.gg
CompletedNCT01293383Updated Feb 24, 2025

A Study Evaluating the Safety of LEO 90105 and Its Vehicle, After Multiple Administration on Intact Skin of Healthy Japanese Male Subjects

A Phase 1 interventional study of LEO 90105 in Healthy, sponsored by LEO Pharma. Completed at 1 site in Japan. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-24.

Sponsored by LEO Pharma · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

The purpose of this trial is to to investigate the safety of LEO 90105 compared with its vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male subjects.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy Japanese male subjects
  • Aged 20 to 40 years inclusive
  • Subjects without signs of skin irritation (erythema, dryness, roughness or scaling) on the test site
  • 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

Exclusion criteria

Exclusion Criteria:

  • Subjects with Body mass Index (BMI ) (body weight(kg)/height (m)²) outside the range 18-25 kg/m2(18≤BMI\<25)
  • Subjects with history of alcohol, chemical or drug abuse
  • Subjects with history of allergic reaction to any content of the study medication
  • Subjects with systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
  • Subjects with known sensitivity to any component of any of the formulations being tested
  • Subjects with known hepatic, renal or cardiac disorders
  • Subjects using systemic, locally injected or inhaled corticosteroids within 4 weeks of study start (Day 1)
  • Subjects using systemic vitamin D analogues,vitamin D or calcium supplements within 4 weeks of study start (Day 1)
  • Subjects using any drug (systemic or topical) within 2 weeks of study start (Day 1)
  • Subjects using 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
  • Subjects with any abnormality found at medical interview before administration of the test drug, which will affect the clinical study as judged by the investigator
  • Subjects with history of or active photo-induced or photo-aggravated disease (abnormal response to the sun light)
  • Subjects with exposure to excessive or chronic ultraviolet (UV) radiation i.e., sunbathing, tanning salon use, phototherapy) within four weeks prior to study start (Day 1) or planned during the study period
  • Subjects with 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
  • Subjects with any condition which, in the opinion of the investigator, would place the subject at an unacceptable risk if he participated in the study
  • Subjects with 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)
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
12 participants (actual)

Study arms

  • Other
    LEO 90105

    Drug: LEO 90105

  • Other
    Vehicle

    Drug: LEO 90105

Interventions

  • DrugLEO 90105

    Ointment

06

What researchers measure

Primary outcomes

  1. Skin irritation

    Time frame: 6 days

07

Study locations

1 site
  • Hakata Clinic LTA Clinical Pharmacology Center
    Fukuoka, 812-0025, Japan
08

References and documents

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01293383
Lead sponsor
LEO Pharma
Collaborators
Quintiles, Inc.
Responsible party
Sponsor
First posted
Feb 10, 2011
Start date
Mar 2011
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Feb 24, 2025

Study contacts

Masanari Shiramoto, MD., PhD
principal investigator · Hakata Clinic LTA Clinical Pharmacology Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion