Study for Treatment With Calcipotriol/Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris — TRIANGLE  

Psoriasis Vulgaris Clinical Trial

Official title: Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris

Status Completed

Clinical Trial Summary

The combination of calcipotriol and betamethasone dipropionate used in an ointment formulation (Daivobet® ointment) has shown to have an excellent efficacy and safety in the short-term and long-term management of psoriasis vulgaris. A newly developed gel formulation (Xamiol® gel) of calcipotriol and betamethasone dipropionate has recently been approved and marketed in Korea as a topical treatment of moderate to severe scalp psoriasis and non-scalp psoriasis vulgaris.

Xamiol® gel, the investigational product (IP) used in this study, prevents keratinization by normalizing the reproduction cycle of skin cells. It also relieves itching associated with psoriasis. Xamiol® gel was initially approved for treatment of moderate to severe scalp psoriasis and its label was extended to non-scalp psoriasis vulgaris in October 2012.

Since patient compliance is one of the important factors in achieving effective outcomes in the treatment of psoriasis, the once daily dosing of Xamiol® gel is expected to enhance compliance and treatment outcomes as well as to provide a safe and effective therapeutic option.

Clinical Trial Description

Psoriasis is a disease difficult to cure and is usually recurrent and therefore, a continued management is crucial. An evidence-based approach is important for appropriate treatments of patient with psoriasis. However, there is a lack of response data for the topical treatments in Asian patients with psoriasis, and no treatment guidelines available. Therefore, routine topical treatments, instead of patient-specific treatments, are usually applied, which may result in treatment failure. In this regard, it is imperative to conduct a study to assess topical treatments in Korean patients with psoriasis vulgaris in terms of efficacy and side effects.

Furthermore, psoriasis patients in Korea, mostly small plaque types, may exhibit different disease activities and response outcomes and accordingly require different treatment options as compared to Western populations whose dominant psoriasis type is large plaque type. Thus, a study in Korean patients with psoriasis may reveal an interesting finding.

In order to investigate optimal maintenance regimens for the topical treatment of Korean patients with psoriasis vulgaris, we are planning this study which evaluates the efficacy of three 8-week maintenance regimens containing Xamiol® gel (PRN treatment group, Continuous treatment group and Twice weekly treatment group) in patients who have become "Responder" after 8-week induction therapy with Xamiol® gel ("Responder").

The primary objective of this study is to evaluate the percentages of "Responder"* at week 16, as assessed by Investigator's Global Assessment of Disease Severity (IGA), in three different 8-week maintenance regimens of Xamiol® gel after 8-week induction treatment with Xamiol® gel in patients with psoriasis vulgaris.

• Responder is defined as subjects with "clear" or "almost clear" according to IGA.

Secondary study objectives is to evaluate efficacy, % of Relapse and time to Relapse, PGA, Patient Compliance, Safety and Quality of Life (DLQI and TSQM) in three arms with calcipotriol/betamethasone dipropionate combination gel treatment in Korean patients with chronic plaque psoriasis of the body. ;

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

• NCT number: NCT02004574
• Study type: Interventional
• Source: Samsung Medical Center
• Status: Completed
• Phase: Phase 4
• Start date: October 2013
• Completion date: June 2014