At a glance
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Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol /Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
In Brief
A Phase 4 clinical trial evaluating Calcipotriol/betamethasone dipropionate gel for Psoriasis Vulgaris. Completed, enrolled 201 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
All enrolled subjects will receive Xamiol® gel once daily for 8 weeks during the induction period and then will be assessed according to IGA at the end of 8-week induction period. Those subjects determined to be "Responder" by IGA will be randomized to one of the following three treatment groups and they will continue their therapy with randomized maintenance regimens for the duration of additional 8 weeks.