Rosacea
Conditions
Interventions
SKE-18, vehicle are applied.
Sponsors
Kasumi Sanpei
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese males or female aged 18 years or older at the time of signing the Informed Consent Form 2. Patients diagnosed with rosacea 3. Patients with moderate to severe persistent facial erythema associated with rosacea 4. Patients who received full explanations regarding the objective of the study, details of the study and the study drug and provided voluntary written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with severe or unstable or uncontrolled cardiovascular disease, or with a medical history of such disease 2. Patients with uncontrolled hypertension or hypotension 3. Patients with cerebral or coronary insufficiency, Raynaud's syndrome thromboangiitis obliterans, scleroderma, Sjogren's syndrome 4. Patients with closed-angle glaucoma or open-angle glaucoma with a narrow-angle eye 5. Patients with inflammatory lesions (papules and pustules) of >=4 on the face 6. Patients with significant intra- and inter-day fluctuations in erythema associated with rosacea 7. Patients considered ineligible for the study by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters and plasma concentration-time profile of SKE-18 | — |
Contacts
Public ContactClinical Trials Information Desk
Sato Pharmaceutical Co., Ltd.
Outcome results
None listed