A clinical pharmacology, single topically dose study to evaluate the safety and pharmacokinetics of M605110 in patients with acne vulgaris

JRCT ID: jRCT2031220537

Registered date:25/12/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acne vulgaris
• Date of first enrollment: 04/02/2023
• Target sample size: 16
• Study type: Interventional
• Intervention(s): 5%M605110 or M605110 placebo will be administered to affected area of patients singlely.

Outcome(s)

• Primary Outcome: Safety, Pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 49age old
• Gender: Male
• Include criteria: Patients with acne vulgaris who are 18 to 49 years of age at the time of informed consent

Exclude criteria

(1)Patients with a history or merger of cardiac, hepatic, plumonary, renal, hematologic, or other diseases considered inappropriate for paticipation in the clinical study
(2)Patients with inflamed cysts/induration
(3) Patients with diseases other than acne vulgaris at the planned application site of study drug
(4)Patients who are judged to be clinically abnormal by the principal (sub) investigator based on clinical tests, vital signs, and electrocardiogram
(5)Patients who are judged to be unsuitable as subject by the principal (sub) investigator

Related Information

• Primary Sponsor: Tomoyuki Nishiura