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 Study Evaluating the Safety of LEO 90105 and Its Vehicle, After Multiple Administration on Intact Skin of Healthy Japanese Male Subjects. A Single Centre, Prospective, Randomised, Double-blinded, Vehicle-controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LEO 90105

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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:

• 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)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Vehicle	Drug: LEO 90105; Ointment
Other: LEO 90105	Drug: LEO 90105; Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin irritation	6 days

Collaborators and Investigators

• Sponsor: LEO Pharma
• Collaborators: Quintiles, Inc.
• Investigators: Principal Investigator: Masanari Shiramoto, MD., PhD, Hakata Clinic LTA Clinical Pharmacology Center

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: February 9, 2011
• First Submitted That Met QC Criteria: February 9, 2011
• First Posted (Estimate): February 10, 2011

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: MCB 0902