Plaque Psoriasis
Conditions
Interventions
An appropriate amount of the investigational product (Dovobet Gel) is applied to plaque psoriasis lesions on the body once daily for 12 weeks. The maximum weekly dose allowed is 90 g.
Sponsors
Nakagawa Hidemi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with plaque psoriasis on the body (including those with psoriatic arthritis). 2) Plaque psoriasis patients with poor adherence (= 20 years old who provide written informed consent to participation in the study.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or possibly pregnant, or who wish to become pregnant during the study period. 2) Breast-feeding women. 3) Patients with known allergy or possible allergy to any component of the investigational product. 4) Patients with bacterial, fungal, spirochetal, or viral skin infection or parasite infestation (scabies, hair lice, etc.), and patients with any of these diseases that could potentially be aggravated. 5) Patients with skin ulcers (other than due to Behcet's disease) and those with second or third-degree burns or frostbite. 6) Patients who have previously used the investigational product for treatment of lesions on the body. 7) Patients who have received Tigason during the following period before the start of study treatment: within six months before the start of study treatment for men, or within one year before the start of study treatment for women. 8) Patients who have received systemic treatment with the following biological product during each period before the start of study treatment: -Adalimumab, Infliximab, Ixekizumab or Guselkumab: within three months before the start of study treatment. -Ustekinumab: within four months before the start of study treatment. -Secukinumab or Brodalumab: within five months the before the start of study treatment. 9) Patients with symptom of severe renal failure, liver dysfunction or cardiac disease. 10) Patients with symptom of hypercalcemia. 11) Other patients who are considered to be unsuitable for the study by the investigator or subinvestigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Drug preference of the subjects in Week 4 and Week 12 (determined by using the Patient Preference Questionnaire). 2)Comparison of patient satisfaction (TSQM-9) between baseline (Week 0) and Weeks 4 and 12. 3) Comparison of the PGA between baseline (Week 0) and Weeks 4 and 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Comparison of per protocol treatment rate between previous treatment and the study treatment in Weeks 4, 8 and 12. 2)Comparison of the application time between previous treatment and the study treatment in Weeks 4, 8 and 12. 3)Comparison of the PGA between baseline and Week 8. 4)Comparison of the mean modified Psoriasis Area and Severity Index (m-PASI) and mean percent change between baseline and Weeks 4, 8 and 12. 5)Comparison of patient satisfaction (TSQM-9) between baseline and Week 8. 6)Comparison of the BSA affected by psoriasis between baseline and Weeks 4, 8 and 12. 7)Comparison of pruritus (Itch Numerical Rating Scale: NRS) between baseline and Weeks 4, 8 and 12. | — |
Contacts
Public ContactHidemi Nakagawa
Atago Dermatology
Outcome results
None listed