rosacea
Conditions
Interventions
investigational material(s)
Generic name etc : Metronidazole
INN of investigational material : Metronidazole
Therapeutic category code : 269 Other agents for epidermis
Dosage and Administration for In
Sponsors
Maruho Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: rosacea patients
Exclusion criteria
Exclusion criteria: (1) Patients with a history of, or currently with any of the following diseases: 1) Serious allergy (shock, anaphylactoid symptoms) 2) Allergy to metronidazole or study drug 3) Cutaneous hypersensitivity to topical drugs (e.g., allergic contact dermatitis, irritability) (2) Patients with any of the following diseases: 1) Diseases considered inappropriate for study participation, such as serious cardiac, hepatic, renal, pulmonary, or hematologic diseases 2) Structural disease with brain or spinal cord 3) Malignant tumor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy confirmatory pharmacodynamics The proportion of subjects achieving the treatment success at week 12 Investigator evaluates the treatment success in terms of percent changes of inflammatory lesion counts and the changes of erythema severity from baseline (to Week 12) . | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy confirmatory pharmacodynamics Percent change of inflammatory lesion counts from baseline Count inflammatory lesion at every visit efficacy confirmatory pharmacodynamics Change of erythema severity from baseline Evaluate erythema severity on every visit | — |
Countries
Japan
Outcome results
None listed