Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

NCT02379793 | Completed Phase 1

• 1 other identifier: LP0076-1080
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.

Conditions

Skin and Connective Tissue Diseases

Keywords

LEO 80185 gel; calcipotriol; betamethasone

Outcome Measures

Primary Outcomes (1)

• Skin irritation measured as -, +/-, +, ++, +++, ++++

  4 days

Study Arms (1)

LEO 80185 gel, vehicle, liquid paraffin

EXPERIMENTAL

Each subject has all 3 treatments applied topically at the same time. However, the location on which the treatments are applied is randomised in an investigator blinded manner.

Drug: LEO 80185 gel, vehicle, liquid paraffin

Interventions

LEO 80185 gel, vehicle, liquid paraffin DRUG

Each subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject.

LEO 80185 gel, vehicle, liquid paraffin

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent has been obtained.
• Healthy Japanese male subjects.
• Aged 20 to 40 years inclusive.
• Subjects without signs of skin irritation/disease/disorders/symptoms or blemishes on test sites (e.g. erythema, dryness, roughness, scaling, scars, moles, sunburn).
• Subjects without a significant abnormality, as judged by the (sub)investigator

You may not qualify if:

• Body Mass Index outside the range 18-25 kg/m²
• History of alcohol or drug abuse.
• History of allergic reaction to any medications.
• Any disease that could in any way confound assessment of the test sites.
• Known or suspected hypersensitivity to any component of LEO 80185 gel.
• Known or suspected hepatic, renal or cardiac disorders.
• Known or suspected disorders of calcium metabolism associated with hypercalcaemia or albumin-corrected serum calcium above the reference range from the sample taken during screening.
• Subjects suspected of infection based on the infection testing results from the sample taken during screening (Hepatitis B surface antigen, HCV antibody, HIV antigen/antibody, serological test for syphilis).
• Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
• Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
• Use of any medication (systemic or topical) within 2 weeks of Day 1.
• Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within 4 weeks or 5 half-lives of Day 1, whichever is longest.
• Current participation in any other interventional clinical trial.
• Previously enrolled in this clinical trial.
• Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (1)

Medical Co. LTA HAKATA Clinic

Random Square 5F, 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025, Japan

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Conditions

Skin and Connective Tissue Diseases

Interventions

Mineral Oil

Intervention Hierarchy (Ancestors)

Petrolatum; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 5, 2015
• Study Start: March 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: February 24, 2025

Record last verified: 2015-02

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)