Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

Skin Irritation Test of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects

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

Study Overview

• Status: Completed
• Conditions: Skin and Connective Tissue Diseases
• Intervention / Treatment: Drug: LEO 80185 gel, vehicle, liquid paraffin

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Fukuoka
    • Random Square 5F, 6-18 Tenyamachi, Hakata-ku, Fukuoka, Japan, 812-0025
      • Medical Co. LTA HAKATA Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Body Mass Index outside the range 18-25 kg/m²
2. History of alcohol or drug abuse.
3. History of allergic reaction to any medications.
4. Any disease that could in any way confound assessment of the test sites.
5. Known or suspected hypersensitivity to any component of LEO 80185 gel.
6. Known or suspected hepatic, renal or cardiac disorders.
7. 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.
8. 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).
9. Use of systemic, locally injected or inhaled corticosteroids within 4 weeks of Day 1.
10. Use of vitamin D or calcium supplements, or systemic vitamin D analogues within 4 weeks of Day 1.
11. Use of any medication (systemic or topical) within 2 weeks of Day 1.
12. 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.
13. Current participation in any other interventional clinical trial.
14. Previously enrolled in this clinical trial.
15. Previous or current photo-induced or photo-aggravated disease (e.g. abnormal response to sunlight).
16. Exposure to excessive or chronic ultraviolet radiation (e.g. sunlight, sun lamps, tanning booths or photo-therapy) within 4 weeks of Day 1.
17. Subjects (or their partner) not using an adequate method of contraception during the trial (Day 1-4).
18. In the opinion of the (sub)investigator, participation in the trial is inappropriate.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 80185 gel, vehicle, liquid paraffin; 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; Each subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Skin irritation measured as -, +/-, +, ++, +++, ++++	4 days

Collaborators and Investigators

• Sponsor: LEO Pharma

Publications and helpful links

Helpful Links

• Clinical Trials at LEO Pharma

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: March 4, 2015
• First Posted (Estimated): March 5, 2015

Study Record Updates

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

More Information

Terms related to this study

• Keywords: LEO 80185 gel; calcipotriol; betamethasone
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Dermatologic Agents; Emollients; Mineral Oil
• Other Study ID Numbers: LP0076-1080

Plan for Individual participant data (IPD)

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