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

NCT02004574 | Completed Phase 4

• 1 other identifier: KSPLK 2013-01
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Investigator's global assessment of disease severity

  Week 0, 4, 8, 12 and 16

• Percentage of disease relapse

  Week 0, 4, 8, 12 and 16

• Patient's global assessment of disease severity

  Week 0, 4, 8, 12 and 16

• Change in Psoriasis Area and Severity Index (PASI) score from Baseline to Week

  Week 0, 4, 8, 12 and 16

• Percent of subjects achieving a 75% improvement in the Psoriasis Area and Severity Index (PASI) score

  Week 0, 4, 8, 12 and 16

Other Outcomes (8)

• Subject's Compliance

  Week 4, 8, 12 and 16

• Dermatology Life Quality Index

  Week 0, 4, 8, 12 and 16

• Treatment Satisfaction Questionnaire for Medication

  Week 8 and 16

Study Arms (3)

PRN treatment

EXPERIMENTAL

Group 1: PRN treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel) once daily as needed (PRN)

Drug: Calcipotriol/betamethasone dipropionate gel

Continuous treatment

EXPERIMENTAL

Group 2: Continuous treatment Apply Xamiol® gel (Calcipotriol/betamethasone dipropionate gel)once daily

Drug: Calcipotriol/betamethasone dipropionate gel

Weekends treatment

EXPERIMENTAL

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

Interventions

Calcipotriol/betamethasone dipropionate gel DRUG

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.

Also known as: Xamiol gel

Continuous treatment; PRN treatment; Weekends treatment

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged 19 years and above
• 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
• An investigator's global assessment of disease severity(IGA) of at least mild on the body (trunk and/or limbs) at Day 0 (Baseline)
• 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
• Able to communicate with the investigator and understand and comply with the requirements of the study
• 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

You may not qualify if:

• 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
• Subjects with unstable forms of psoriasis including guttate, erythrodermic, exfoliative and pustular psoriasis, or psoriatic arthritis
• Subjects with known disorders of calcium metabolism/hypercalcemia
• Subjects with hypersensitivity to the active substances or to any of the excipients of the investigational products
• 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
• 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
• Phototherapy within the following time periods prior to baseline visit
• PUVA or Grenz ray - within 4 weeks
• UV-B - within 2 weeks
• Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to baseline visit

Sponsors & Collaborators

• Jooheung Lee: lead

Study Sites (1)

Samsung Medical Center

Gangnam-gu, Seoul, 135-710, South Korea

Location

Related Publications (7)

• Lowes MA, Bowcock AM, Krueger JG. Pathogenesis and therapy of psoriasis. Nature. 2007 Feb 22;445(7130):866-73. doi: 10.1038/nature05663.

  PMID: 17314973 RESULT

• 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. doi: 10.1111/j.0007-0963.2004.05891.x.

  PMID: 15099362 RESULT

• 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;143(2):239-42. doi: 10.1001/archderm.143.2.239.

  PMID: 17310004 RESULT

• Kragballe K, Austad J, Barnes L, Bibby A, de la Brassinne M, Cambazard F, Fleming C, Heikkila 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 dipropionate two-compound product (Daivobet/Dovobet/Taclonex) in the treatment of psoriasis vulgaris. Dermatology. 2006;213(4):319-26. doi: 10.1159/000096069.

  PMID: 17135738 RESULT

• 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 vulgaris. Br J Dermatol. 2004 Jun;150(6):1167-73. doi: 10.1111/j.1365-2133.2004.05986.x.

  PMID: 15214905 RESULT

• Langley RG, Gupta A, Papp K, Wexler D, Osterdal 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. Dermatology. 2011;222(2):148-56. doi: 10.1159/000323408. Epub 2011 Feb 3.

  PMID: 21293107 RESULT

• 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. No abstract available.

  PMID: 23097521 RESULT

MeSH Terms

Interventions

calcipotriene; betamethasone dipropionate, calcipotriol drug combination

Study Officials

• Joo-Heung Lee, MD

  Samsung Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 10, 2013
• First Posted: December 9, 2013
• Study Start: October 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 4, 2014

Record last verified: 2014-06

Locations

KR (1)