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Trial record 33 of 565 for:    applied AND irritation

Skin Irritation Test of LEO 80185 Gel in Healthy Japanese Subjects

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ClinicalTrials.gov Identifier: NCT02379793
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : June 14, 2016
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Skin and Connective Tissue Diseases Drug: LEO 80185 gel, vehicle, liquid paraffin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Skin Irritation Test of LEO 80185 Gel (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Study Start Date : March 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

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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.




Primary Outcome Measures :
  1. Skin irritation measured as -, +/-, +, ++, +++, ++++ [ Time Frame: 4 days ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02379793


Locations
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Japan
Medical Co. LTA HAKATA Clinic
Random Square 5F, 6-18 Tenyamachi, Hakata-ku, Fukuoka, Japan, 812-0025
Sponsors and Collaborators
LEO Pharma

Additional Information:
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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT02379793     History of Changes
Other Study ID Numbers: LP0076-1080
First Posted: March 5, 2015    Key Record Dates
Last Update Posted: June 14, 2016
Last Verified: February 2015

Keywords provided by LEO Pharma:
LEO 80185 gel
calcipotriol
betamethasone

Additional relevant MeSH terms:
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Connective Tissue Diseases
Betamethasone
Calcipotriene
Mineral Oil
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Emollients