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A Phase I, repeated application study with SKE-18 1% cream in patients with persistent facial erythema associated with rosacea

A Phase I, repeated application study with SKE-18 1% cream in patients with persistent facial erythema associated with rosacea

Kasumi Sanpei

Sato Pharmaceutical Co., Ltd.

1-5-27, Motoakasaka, Minato-Ku, Tokyo

clinicaltrials-info@sato-seiyaku.co.jp

Clinical Trials Information Desk

Sato Pharmaceutical Co., Ltd.

1-5-27, Motoakasaka, Minato-Ku, Tokyo

+81-3-5412-7329

clinicaltrials-info@sato-seiyaku.co.jp

Recruiting

Sept. 01, 2024

Interventional

randomized controlled trial

double blind

placebo control

crossover assignment

treatment purpose

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

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

Both

Rosacea

SKE-18, vehicle are applied.

Pharmacokinetic parameters and plasma concentration-time profile of SKE-18

+81-3-5366-3006

Aug. 14, 2024

No

none