Psoriasis vulgaris -
Conditions
Interventions
Prevention of psoriasis
Sponsors
Morita Akimichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects diagnosed with moderate or higher psoriasis vulgaris. Subjects with arthrosis psoriasis can be entered 2) Subject is male and female,80 > years of age ,20 <= years of age 3) Baseline BSA 5% <= or sPGA score 3 <= 4) Subjects with insufficient effect by topical therapy for external preparations
Exclusion criteria
Exclusion criteria: 1) Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study 2) Subject has a known hypersensitivity to any excipients of Apremilast 3) Subject has a known hypersensitivity to any excipients of phototherapy 4) Patients diagnosed with psoriasis other than psoriasis vulgaris, arthropathic psoriasis 5) Subjects who are known to have insufficient phototherapy 6) Subject has concurrent skin malignancy or history of skin malignancy . However, if there is no recurrence for the past 5 years it will be accepted 7) Subjects with high carcinogenic risk (patients with pigmentosal xeroderma, arsenic oral contact and contact history, radiation exposure history) 8) Subjects with psoriasis recurrence / relapse within 4 weeks before baseline started 9) Subjects do not want/avoid long-time sunlight or UV light 10) Subjects have been treated with Study drugs 11) Subjects have been treated with Chigason within 12 weeks before baseline patient 12) Subjects have been treated with biologics agent that is Indications for psoriasis within 12 weeks before baseline patient. However, patients who have been treated with Secukinumab or Risankizumab within 24 weeks prior to the start of treatment are not eligible. 13) Subjects have been treated with cyclosporine or methotrexate within 4 weeks before baseline 14) Subjects have been irradiated skin with UVA or UVB within 2 weeks before baseline 15) Subjects have been treated with Strongest's external steroid within 2 weeks before baseline 16) Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Individual improvement rate from PASI treatment start date to 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| (Evaluation of effectiveness) Individual improvement rate of PASI from baseline to 4 weeks Achievement rate of PASI-75, PASI-90, PASI-50 after 4 weeks and 8 weeks Individual change amount from PASI treatment start date to 4 weeks and 8 weeks Individual rate of change from the treatment start date of BSA to 4 weeks and 8 weeks Achievement rate of sPGA 0/1 and 0 after 4 weeks and 8 weeks Individual change amount from 4 weeks to 8 weeks from the treatment start date of EQ-5D-5L Individual change amount from DLQI treatment start date to 4 weeks and 8 weeks Individual change amount of 4 weeks and 8 weeks from the treatment start date of itching VAS Individual change amount from 4 weeks to 8 weeks from the treatment start date of cytokines(IL-2, IL-4, IL-6, IL-10, IL-17A, IL-17F, IL-22, IL-23, INF-g, TNF-(alpha)) (Safety Assessment) Adverse event and side effects Clinical laboratory values (Immune serological examination, Hematological examination, Biochemical examination, Exploratory inspection) (Treatment status) Apremilast administration status Irradiation frequency and irradiation dose of phototherapy Combination drug and combination therapy | — |
Contacts
Public ContactAkimichi Morita
Nagoya City University Hospital
Outcome results
None listed