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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293383
• Other study ID #: MCB 0902
• Status: Completed
• Phase: Phase 1
• First received: February 9, 2011
• Last updated: March 25, 2015
• Start date: March 2011
• Est. completion date: March 2011

Study information

• Verified date: March 2015
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LEO 90105
Ointment

Locations

Country	Name	City	State
Japan	Hakata Clinic LTA Clinical Pharmacology Center	Fukuoka

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Quintiles, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin irritation		6 days	Yes

External Links

•   Clinical Trials at LEO Pharma