Investigation of patient satisfaction and efficacy of Dovobet Gel in psoriasis patients with poor adherence

JRCT ID: jRCTs031180049

Registered date:01/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Plaque Psoriasis
• Date of first enrollment: 07/01/2019
• Target sample size: 50
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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.

Exclude 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.

Related Information

• Primary Sponsor: Nakagawa Hidemi
• Source(s) of Monetary Support: LEO Pharma K.K.