A Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects

NCT01293357 | Completed Phase 1

• 1 other identifier: MCB 0901
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the trial is to investigate skin irritation, phototoxicity and safety of LEO 90105 and its components by patchtest (48 hours closed patch test and photo patch test) in healthy Japanese male subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Skin irritation

  5 days

Study Arms (1)

Patches

EXPERIMENTAL

Drug: LEO 90105

Interventions

LEO 90105 DRUG

Ointment

Patches

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 test sites.
• 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:

• Body mass Index (BMI ) (body weight (kg)/height(m)²) outside the range 18-25 kg/m2
• History of alcohol, chemical or drug abuse
• History of allergic reaction to drugs or history of skin reaction to the tape
• Any systemic or cutaneous disease that could in any way confound interpretation of the study results (e.g. atopic dermatitis, eczema, psoriasis)
• Known sensitivity to any component of any of the formulations being tested
• Known hepatic or renal disorders
• Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of study start (Day 1)
• Use of systemic vitamin D analogues, vitamin D or calcium supplements within 4 weeks of study start(Day 1)
• Use of any drug (systemic or topical) within 2 weeks of study start (Day 1)
• Use of 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
• Any abnormality found at medical interview before administration of the test drug, which will affect the clinical study as judged by the investigator
• History of or active photo-induced or photoaggravated disease (abnormal response to the sun light)
• 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
• Any condition which, in the opinion of the investigator, would place the subject at an unacceptable risk if he participated in 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 Clinica LTA Clinical Pharmacology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2011
• First Posted: February 10, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 24, 2025

Record last verified: 2015-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)