A Phase 3 study of M512102 with impetigo.

A Phase 3, Randomized, Unlind, Multi-Center, Parallel Group Study to evaluate Efficacy, Safety and Microbiological effect of M512102 in Subjects with impetigo.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224574

Enrollment

Registered

2019-02-27

Start date

2019-03-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impetigo

Interventions

investigational material(s) Generic name etc : Ozenoxacin INN of investigational material : Ozenoxacin Therapeutic category code : 263 Dermatics for purulence Dosage and Administration for Investigati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Impetigo patients

Exclusion criteria

Exclusion criteria: (1)Subjects with a history of any of the following diseases 1)Drug hypersensitivity to quinolone antibiotics 2)Cutaneous hypersensitivity to topical medicines (2)Subjects with the Clinically significant liver, kidney, heart, or lung diseases that require hospitalization

Design outcomes

Primary

Measure	Time frame
efficacy The clinical effect at final evaluation.	—

Secondary

Measure	Time frame
safety Bacterial negative rate at final evaluation	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026