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

NCT01293383 | Completed Phase 1

• 1 other identifier: MCB 0902
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Skin irritation

  6 days

Study Arms (2)

LEO 90105

OTHER

Drug: LEO 90105

Vehicle

OTHER

Drug: LEO 90105

Interventions

LEO 90105 DRUG

Ointment

LEO 90105; Vehicle

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• LEO Pharma: lead
• Quintiles, Inc.: collaborator

Study Sites (1)

Hakata Clinic LTA Clinical Pharmacology Center

Fukuoka, 812-0025, Japan

Location

Related Links

• Clinical Trials at LEO Pharma

Study Officials

• Masanari Shiramoto, MD., PhD

  Hakata Clinic LTA Clinical Pharmacology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: March 1, 2011
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)