A phase III, randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of M605108 in patients with acne vulgaris

JRCT ID: jRCT2031200251

Registered date:16/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Acne vulgaris
• Date of first enrollment: 26/11/2020
• Target sample size: 200
• Study type: Interventional
• Intervention(s): Patients apply a sufficient quantity of benzoyl peroxide to cover the entire face (except the lips and around the eyes) once daily at night after they washed and dried their faces.

Outcome(s)

• Primary Outcome: Percentage change in total lesion count from baseline to week 12
• Secondary Outcome: Percentage change in inflammatory lesion and non-inflammatory lesion counts from baseline to week 12

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: <= 49age old
• Gender: Both
• Include criteria: Patients with acne vulgaris

Exclude criteria

-Patients with concurrent presense of serious cardiac, hepatic, renal, plumonary, hematologic, or other diseases considered inappropriate for paticipation in the clinical study
-Patients with a history of hypersensitivity to investigational drug ingredients
-Pregnant or lactating women

Related Information

• Primary Sponsor: Nishiura Tomoyuki