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Investigation of patient satisfaction and efficacy of Dovobet Gel in patients with plaque psoriasis on the body who show poor adherence (INSPADES Study)

Investigation of patient satisfaction and efficacy of Dovobet Gel in psoriasis patients with poor adherence (INSPADES Study)

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The following items were investigated at the time of enrollment. Gender, Age, Height, Weight, Duration of psoriasis, History (within the past year from the date of obtaining consent), Complications, History of treatment for plaque psoriasis (for the 4 weeks before the date of obtaining consent). The patient characteristics in the per protocol set are summarized as follows. The population comprised 26 males and 15 females with a mean age (SD) of 50.5 (15.6) years. The mean (SD) height and weight were 162.26 (8.23) cm and 63.64 (13.02) kg, respectively. The mean (SD) duration of psoriasis was 13.39 (11.44) years.

Enrollment period: December 2018 ~ June 2019 Changes in the number of enrolled cases January : 2 cases February : 3 cases March : 3 cases April : 10 cases May : 15 cases June : 13 cases

In this study, total 12 adverse events were reported. These adverse events occurred in 10 of 46 enrolled patients, with no serious adverse events. Of these adverse events, four were causally related to the investigational product and reported as adverse drug reactions. No new or serious adverse drug reactions were reported.

Patients' preference for the treatment with Dovobet gel compared with their previous treatment was assessed using the PPQ. In all five questions, the treatment with Dovobet gel was highly preferred over the previous topical treatment. More specifically, many patients rated the treatment with Dovobet gel as being "better tolerated" and "easier to use" compared with their previous treatment at both weeks 4 and 12. Treatment satisfaction was assessed using TSQM-9. The longer Dovobet gel was used, the more the convenience score tended to increase. The therapeutic effects of Dovobet gel as assessed by PGA, m-PASI and BSA all increased until week 12.The occurrence of moderate to severe pruritus reduced from week 4 after switching to Dovobet gel. The time requied for application of Dovobet gel was also reduced over time, and from these facts, it is considered that the application adherence was greatly improved.

Because of the high level of patient satisfaction with investigational product (Dovobet gel), especially with regard to its convenience and its sustained therapeutic effect, it is effective in improving treatment adherence. Conversely, the high adherence to Dovobet gel is likely to increase its therepeutic effect. Based on these finding, we expected that Dovobet gel might become the mainstay of topical psoriasis treatment for patients with poor adherence.

July. 31, 2020

Nov. 05, 2020

https://onlinelibrary.wiley.com/doi/10.1111/1346-8138.15522

No

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https://jrct.mhlw.go.jp/latest-detail/jRCTs031180049

Nakagawa Hidemi

Atago Dermatology

SUN-CELMO DAIMON BUILD, 1-1-35 Shibadaimon, Minato-ku, Tokyo

irb@atago-hifuka.jp

Nakagawa Hidemi

Atago Dermatology

SUN-CELMO DAIMON BUILD,1-1-35 Shibadaimon, Minato-ku, Tokyo

+81-3-6402-3636

irb@atago-hifuka.jp

Complete

Dec. 01, 2018

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Patients with plaque psoriasis on the body (including those with psoriatic arthritis).
2) Plaque psoriasis patients with poor adherence (< 60%) and no clinical effect during the 4 weeks before the start of study treatment with regard to use of topical drugs other than the investigational product (topical activated vitamin D3, topical steroids, or in-house mixed preparations of them, or topical fixed combination drugs containing topical steroid and activated vitamin D3).
3) Patients with psoriasis affecting <= 30% of their body surface area (BSA).
4) Patients with a physician's global assessment (PGA) rating of "mild" or higher.
5) Patients aged >= 20 years old who provide written informed consent to participation in the study.

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.

Both

Plaque Psoriasis

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.

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.

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.

+81-3-3265-4804

Nov. 20, 2018

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