Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT02379793
Eligibility 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.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
20 Years
Maximum Age:
40 Years
Study:
NCT02379793
Study Brief:
Protocol Section:
NCT02379793