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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

February 9, 2011
November 8, 2013
March 2011
March 2011   (final data collection date for primary outcome measure)
Skin irritation [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01293383 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Healthy
Drug: LEO 90105
Ointment
  • LEO 90105
    Intervention: Drug: LEO 90105
  • Vehicle
    Intervention: Drug: LEO 90105
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
March 2011
March 2011   (final data collection date for primary outcome measure)

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)
Male
20 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01293383
MCB 0902
No
LEO Pharma
LEO Pharma
Quintiles
Principal Investigator: Masanari Shiramoto, MD., PhD Hakata Clinic LTA Clinical Pharmacology Center
LEO Pharma
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP