Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

Skin and Connective Tissue Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02379793
• Other study ID #: LP0076-1080
• Status: Completed
• Phase: Phase 1
• First received: February 26, 2015
• Last updated: June 13, 2016
• Start date: March 2015
• Est. completion date: April 2015

Study information

• Verified date: February 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 the study is to investigate skin irritation of LEO 80185 gel, gel vehicle and Liquid Paraffin in healthy Japanese male subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Skin and Connective Tissue Diseases

Intervention

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.

Locations

Country	Name	City	State
Japan	Medical Co. LTA HAKATA Clinic	Random Square 5F, 6-18 Tenyamachi, Hakata-ku	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin irritation measured as -, +/-, +, ++, +++, ++++		4 days	Yes

External Links

•   Clinical Trials at LEO Pharma