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

Psoriasis Vulgaris Clinical Trial

— TRIANGLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02004574
• Other study ID #: KSPLK 2013-01
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2013
• Last updated: June 3, 2014
• Start date: October 2013
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Gangnam-gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Jooheung Lee

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, Fleming C, Heikkilä H, Williams Z, Peyri Rey J, Svensson A, Toole J, Wozel G. Efficacy results of a 52-week, randomised, double-blind, safety study of a calcipotriol/betamethasone d — View Citation

Kragballe K, Noerrelund KL, Lui H, Ortonne JP, Wozel G, Uurasmaa T, Fleming C, Estebaranz JL, Hanssen LI, Persson LM. Efficacy of once-daily treatment regimens with calcipotriol/betamethasone dipropionate ointment and calcipotriol ointment in psoriasis vu — View Citation

Langley RG, Gupta A, Papp K, Wexler D, Østerdal ML, Curcic D. Calcipotriol plus betamethasone dipropionate gel compared with tacalcitol ointment and the gel vehicle alone in patients with psoriasis vulgaris: a randomized, controlled clinical trial. Dermat — View Citation

Lew W, Lee E, Krueger JG. Psoriasis genomics: analysis of proinflammatory (type 1) gene expression in large plaque (Western) and small plaque (Asian) psoriasis vulgaris. Br J Dermatol. 2004 Apr;150(4):668-76. — View Citation

Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. Review. — View Citation

Pariser DM, Bagel J, Gelfand JM, Korman NJ, Ritchlin CT, Strober BE, Van Voorhees AS, Young M, Rittenberg S, Lebwohl MG, Horn EJ; National Psoriasis Foundation. National Psoriasis Foundation clinical consensus on disease severity. Arch Dermatol. 2007 Feb; — View Citation

Samarasekera E, Sawyer L, Parnham J, Smith CH; Guideline Development Group. Assessment and management of psoriasis: summary of NICE guidance. BMJ. 2012 Oct 24;345:e6712. doi: 10.1136/bmj.e6712. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Subject's Compliance	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
Other	Dermatology Life Quality Index	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
Other	Treatment Satisfaction Questionnaire for Medication	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	Other treatment after completion of study	To evaluate descriptive statistics for used other medication after study completion.	Week 16
Other	Laboratory assessment	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
Other	SAEs	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
Other	AEs	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
Other	ADRs	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
Primary	Percentage of "Responder" (subjects with a grade of "clear" or "almost clear") according to IGA at 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	Investigator's global assessment of disease severity	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
Secondary	Percentage of disease relapse	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
Secondary	Patient's global assessment of disease severity	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
Secondary	Change in Psoriasis Area and Severity Index (PASI) score from Baseline to Week	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
Secondary	Percent of subjects achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score	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
Secondary	Time to relapse	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