Ignite Creation Date:
2024-05-06 @ 2:16 AM
Last Modification Date:
2024-10-26 @ 11:16 AM
Study NCT ID:
NCT02004574
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2013-11-10
Brief Title:
Study for Treatment With CalcipotriolBetamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
Sponsor:
Jooheung Lee
Organization:
Samsung Medical Center
Study Overview
Official Title:
Investigator Initiated Study for Optimal Maintenance Treatment With Calcipotriol Betamethasone Dipropionate Gel in Korean Patients With Psoriasis Vulgaris
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRIANGLE
Brief 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
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
Detailed 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 Investigators 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 calcipotriolbetamethasone dipropionate combination gel treatment in Korean patients with chronic plaque psoriasis of the body
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 Investigators 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 calcipotriolbetamethasone dipropionate combination gel treatment in Korean patients with chronic plaque psoriasis of the body
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None