Plaque Psoriasis
Conditions
Interventions
Part 1: Vehicle control period
Treatment Group: Roflumilast cleam (2 doses) is applied once daily for 8 weeks.
Control Group: Vehicle is applied once daily for 8 weeks.
Part 2: Maintenance treatment
Sponsors
Inoue Hiroshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female patients aged >- 2 years at screening - Patents with a diagnosis of psoriasis vulgaris persisting for at least 6 months by the investigator or subinvestigator based on the information at the time of screening, and whose symptoms have been stable for 4 weeks prior to screening - Patients whose %BSA affected, IGA score and PASI score meet the criteria specified in the study protocol
Exclusion criteria
Exclusion criteria: - Patients who cannot complete the washout of the prohibited medications/therapies prior to the baseline or who cannot discontinue the prohibited medications/therapies during the study - Patients for whom excessive exposure of the investigational product application site to natural or artificial sunlight, tanning beds, or other LEDs is planned - Patients who are pregnant, lactating, or planning to become pregnant during the study period. Participation due to breastfeeding interruption is not permitted - Patients who have received roflumilast cream or roflumilast foam in the past - Patients with any serious medical condition or laboratory abnormality that, in the opinion of the investigator or subinvestigator, would interfere with the patient's participation in this study or pose a significant risk to the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IGA success rate at Week 8 IGA success rate: The proportion of subjects achieving an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement from baseline. | — |
Contacts
Public ContactClinical Trials Information Desk
Sato Pharmaceutical Co., Ltd.
Outcome results
None listed