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

A Phase 1 Study Evaluating Skin Irritation, Phototoxicity and Safety After Administration of LEO 90105 on Intact Skin of Healthy Japanese Male Subjects A Single Centre, Randomised, Controlled, Investigator Blinded Study With Intra-individual Comparison of the Active Formulation and Its Components

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 20
• 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

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 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.

Exclusion Criteria:

• 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)
• Exposure to excessive or chronic ultraviolet (UV)radiation (i.e., sunbathing, tanning salon use, phototherapy)within four weeks prior to inclusion (Day 1) or planned during the study period
• 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
• 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

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patches	Drug: LEO 90105; Ointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin irritation	5 days

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Clinical Trials at LEO Pharma

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

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

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 21, 2025
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Eczematous; Photosensitivity Disorders; Dermatitis; Dermatitis, Irritant; Dermatitis, Contact; Dermatitis, Phototoxic
• Other Study ID Numbers: MCB 0901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO