Comparison of phototherapy alone or together with apremilast in psoriasis vulgaris patients

JRCT ID: jRCTs041180012

Registered date:09/11/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Psoriasis vulgaris
• Date of first enrollment: 17/12/2018
• Target sample size: 51
• Study type: Interventional
• Intervention(s): Prevention of psoriasis

Outcome(s)

• Primary Outcome: Individual improvement rate from PASI treatment start date to 8 weeks

Secondary Outcome

(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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Morita Akimichi
• Source(s) of Monetary Support: Amgen K.K.
• Secondary ID(s): -