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

Phase 4

• Conditions: Plaque Psoriasis

• Registration Number: JPRN-jRCTs031180049
• Lead Sponsor: akagawa Hidemi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-01
• Study Completion: 2019-09-19
• Results First Posted: 2020-11-05
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 46

Inclusion 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.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified