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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01293383
First received: February 9, 2011
Last updated: November 8, 2013
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: LEO 90105
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: 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

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • Skin irritation [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: March 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
LEO 90105 Drug: LEO 90105
Ointment
Vehicle Drug: LEO 90105
Ointment

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01293383

Locations
Japan
Hakata Clinic LTA Clinical Pharmacology Center
Fukuoka, Japan, 812-0025
Sponsors and Collaborators
LEO Pharma
Quintiles
Investigators
Principal Investigator: Masanari Shiramoto, MD., PhD Hakata Clinic LTA Clinical Pharmacology Center
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01293383     History of Changes
Other Study ID Numbers: MCB 0902
Study First Received: February 9, 2011
Last Updated: November 8, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

ClinicalTrials.gov processed this record on August 25, 2014