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
Phase 3
- Conditions
- Acne vulgaris
- Registration Number
- JPRN-jRCT2031200251
- Lead Sponsor
- ishiura Tomoyuki
- Brief Summary
This study demonstrated that 2.5% M605108 once-daily for 12 weeks was efficacious in the treatment of patients with acne vulgaris. Moreover, the regimen was considered well tolerated because the incidence of adverse events leading to study drug discontinuation was low and the severity of most adverse events was mild.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 222
Inclusion Criteria
Patients with acne vulgaris
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method