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

June 3, 2014 updated by: Jooheung Lee

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Gangnam-gu, Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subjects aged 19 years and above
  2. Clinical diagnosis of stable psoriasis vulgaris of at least 4 weeks duration involving the non-scalp regions of the body (trunk and/or limbs) amenable to treatment with a maximum of 100 g of topical medication per week at screening
  3. An investigator's global assessment of disease severity(IGA) of at least mild on the body (trunk and/or limbs) at Day 0 (Baseline)
  4. Signed written informed consent prior to performance of any study-specific procedures or assessments, and must be willing to comply with treatment and follow up
  5. Able to communicate with the investigator and understand and comply with the requirements of the study
  6. Women of childbearing potential must have a negative pregnancy test and must use adequate contraception during the treatment phase of the study and for at least 1 week after the last application of study medication

Exclusion Criteria:

  1. Body surface area (BSA) > 10 % or Psoriasis Area and Severity Index (PASI) > 10 at baseline

    * The palm of one hand is approximately 1 percent of the body surface area

  2. Subjects with unstable forms of psoriasis including guttate, erythrodermic, exfoliative and pustular psoriasis, or psoriatic arthritis
  3. Subjects with known disorders of calcium metabolism/hypercalcemia
  4. Subjects with hypersensitivity to the active substances or to any of the excipients of the investigational products

  5. Systemic treatment with biological therapies with a possible effect on psoriasis vulgaris within the following time periods prior to baseline visit

    • etanercept - within 4 weeks prior to baseline
    • adalimumab, alefacept, infliximab - within 2 months prior to baseline
    • ustekinumab - within 4 months prior to baseline
    • investigational product - within 4 weeks/5 half-lives (whichever is longer) prior to baseline
  6. Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, cyclosporine and other immunosuppressants) within 4 weeks prior to baseline visit

  7. Phototherapy within the following time periods prior to baseline visit

    • PUVA or Grenz ray - within 4 weeks
    • UV-B - within 2 weeks
  8. Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to baseline visit
  9. Topical treatment for other relevant skin disorders on the face and flexures (e.g., facial and flexural psoriasis, eczema) with class 1- 5 corticosteroids or vitamin D analogues within 2 weeks prior to baseline visit
  10. Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues within 2 weeks prior to baseline visit
  11. Subjects with severe renal insufficiency
  12. Subjects with severe hepatic disorders
  13. Subjects with a confounding skin condition or disorders against psoriasis evaluation
  14. Subjects with viral (e.g. herpes or varicella) lesions of the skin, fungal or bacterial skin infections, parasitic infections on the treatment area
  15. Subjects with skin manifestations in relation to tuberculosis or syphilis on the treatment area
  16. Subjects with perioral dermatitis, atrophic skin, striae atrophicae on the treatment area
  17. Subjects with fragility of skin veins, ichthyosis on the treatment area
  18. Subjects with acne vulgaris, rosacea, wounds, ulcers, perianal and genital pruritus on the treatment area
  19. Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, anti-malarials, lithium, ACE inhibitors) during the study
  20. Pregnant or lactating female subjects
  21. Subjects who are planning a pregnancy during the entire study period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRN treatment
Group 1: PRN treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily as needed (PRN)
Drug: Calcipotriol/betamethasone dipropionate gel
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.
Other Names:
  • Xamiol gel
Experimental: Continuous treatment
Group 2: Continuous treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel)once daily
Drug: Calcipotriol/betamethasone dipropionate gel
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.
Other Names:
  • Xamiol gel
Experimental: Weekends treatment
Group 3: Weekends treatment (twice weekly) Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily at weekends (on Saturdays and Sundays)
Drug: Calcipotriol/betamethasone dipropionate gel
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.
Other Names:
  • Xamiol gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of "Responder" (subjects with a grade of "clear" or "almost clear") according to IGA at Week 16
Time Frame: Week 16
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.
Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigator's global assessment of disease severity
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate the change of disease severity assessed by IGA in induction treatment phase and compare the IGA disease severity of three different maintenance regimens in the maintenance treatment phase.
Week 0, 4, 8, 12 and 16
Percentage of disease relapse
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate descriptive statistics of three different regimens in the maintenance treatment phase and compare percentage of relapse in threee different regimens.
Week 0, 4, 8, 12 and 16
Patient's global assessment of disease severity
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate the change of disease severity assessed by PGA in induction treatment phase and compare the PGA disease severity of three different maintenance regimens in the maintenance treatment phase.
Week 0, 4, 8, 12 and 16
Change in Psoriasis Area and Severity Index (PASI) score from Baseline to Week
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate the change of PASI in induction treatment phase and compare the PASI of three different maintenance regimens in the maintenance treatment phase.
Week 0, 4, 8, 12 and 16
Percent of subjects achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate the change of PASI75 from week 4 to week 8 in induction treatment phase and compare PASI75 in three different regimens in the maintenance treatment phase.
Week 0, 4, 8, 12 and 16
Time to relapse
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate descriptive statistics of three different regimens in the maintenance treatment phase and compare the time to relapse in threee different regimens.
Week 0, 4, 8, 12 and 16

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject's Compliance
Time Frame: Week 4, 8, 12 and 16
To evaluate subject's compliance by subject's diary, interview, used IP dose and evaluate descriptive statistics for them.
Week 4, 8, 12 and 16
Dermatology Life Quality Index
Time Frame: Week 0, 4, 8, 12 and 16
To evaluate the change of DLQI score in induction treatment phase and evaluate change rate of week 8, week 12 and week 16 compared with baseline in the maintenance treatment phase.
Week 0, 4, 8, 12 and 16
Treatment Satisfaction Questionnaire for Medication
Time Frame: Week 8 and 16
To evaluated descriptive statistics for TSQM score of week 8 in the induction treatment phase and evaluate change rate of week 8, week 16 and from week 8 to week 16 in the maintenance treatment phase.
Week 8 and 16
Other treatment after completion of study
Time Frame: Week 16
To evaluate descriptive statistics for used other medication after study completion.
Week 16
Laboratory assessment
Time Frame: Week 0, 8, 16 and 18

To evaluate the reported values(normal/abnormal) as follows.

: To evaluate change of reported values from baseline to week 8 in induction treatment phase and compare reported values of week 8 and week 16 in three different regimens in the maintenance treatment phase.
Week 0, 8, 16 and 18
SAEs
Time Frame: Week 0, 4, 8, 12, 16 and 18
To evaluate the number of occurrance(subject-based) in each treatment phase and regimen and compare the number of occurrance in three difference regimens in the maintenance treatment phase.
Week 0, 4, 8, 12, 16 and 18
AEs
Time Frame: Week 0, 4, 8, 12, 16 and 18
To evaluate the number of occurrance(subject-based) in each treatment phase and regimen and compare the number of occurrance in three difference regimens in the maintenance treatment phase.
Week 0, 4, 8, 12, 16 and 18
ADRs
Time Frame: Week 0, 4, 8, 12, 16 and 18
To evaluate the number of occurrance(subject-based) in each treatment phase and regimen and compare the number of occurrance in three difference regimens in the maintenance treatment phase.
Week 0, 4, 8, 12, 16 and 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jooheung Lee

Investigators

  • Study Chair: Joo-Heung Lee, MD, Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

June 4, 2014

Last Update Submitted That Met QC Criteria

June 3, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSPLK 2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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