Clinical trial NCT01188928: LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)
Official title: A Phase 3 Study Comparing Once Daily Treatment With Calcipotriol 50 mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension With Betamethasone 0.5 mg/g (as Dipropionate) in the Topical Suspension Vehicle, Calcipotriol 50 mcg/g in the Topical Suspension Vehicle and the Topical Suspension Vehicle Alone in Subjects With Psoriasis Vulgaris on Non-scalp Regions of the Body (Trunk and/or Limbs)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2010-08-26
Enrollment: 1152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and safety of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension with the active components when used individually as monotherapy in the topical suspension vehicle (betamethasone dipropionate in the topical suspension vehicle, calcipotriol in the topical suspension vehicle) and with the topical suspension vehicle alone in the treatment of psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs) in a large phase 3 study. This comparison will ensure a more informed assessment of the benefit/risk ratio of Calcipotriol 50 Mcg/g Plus Betamethasone 0.5 mg/g (as Dipropionate) Topical Suspension while also establishing the optimal treatment duration in psoriasis vulgaris on the non-scalp regions of the body (trunk and/or limbs).


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent obtained prior to any trial related activities (including any washout period).
* Aged 18 years or above
* Either sex
* Any race or ethnicity
* Attending a hospital outpatient clinic or the private practice of a board certified dermatologist.
* Clinical diagnosis of stable plaque psoriasis vulgaris of at least 6 months 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.
* An investigator's global assessment of disease severity (IGA) of mild or moderate on the body (trunk and/or limbs) at Day 0 (Visit 1).
* A minimum modified Psoriasis Area and Severity Index (PASI) score for extent of 2 in at least one body region (i.e. psoriasis affecting at least 10% of arms, and/or 10% of trunk, and/or 10% of legs)
* Females of childbearing potential must have a negative pregnancy test at Day 0 (Visit 1).
* Females of childbearing potential must agree to use a highly effective method of birth control during the study. A highly effective method of birth control is defined as one which results in a low failure rate (less than 1% per year) such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomised partner. The patients must have used the contraceptive method continually for at least 1 month prior to the pregnancy test, and must continue using the contraceptive method for at least 1 week after the last application of study medication. A female is defined as not of child-bearing potential if she is postmenopausal (12 months with no menses without an alternative medical cause), or surgically sterile (tubal ligation/section, hysterectomy or bilateral ovariectomy).
* Able to communicate with the investigator and understand and comply with the requirements of the study.

Exclusion Criteria:

* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris within the following time periods prior to randomisation:

  * etanercept - within 4 weeks prior to randomisation
  * adalimumab, alefacept, infliximab - within 2 months prior to randomisation
  * ustekinumab - within 4 months prior to randomisation
  * experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to randomisation
* 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 randomisation.
* PUVA or Grenz ray therapy within 4 weeks prior to randomisation.
* UVB therapy within 2 weeks prior to randomisation.
* Any topical treatment of the trunk and/or limbs (except for emollients) within 2 weeks prior to randomisation.
* 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 randomisation.
* Topical treatment for other relevant skin disorders on the scalp (e.g. scalp psoriasis) with class 1-5 corticosteroids, vitamin D analogues or prescription shampoos within 2 weeks prior to randomisation.
* 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.
* Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
* Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, perioral dermatitis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, acne rosacea, ulcers and wounds.
* Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
* Known or suspected severe renal insufficiency or severe hepatic disorders.
* Known or suspected hypersensitivity to component(s) of the investigational products.
* Current participation in any other interventional clinical study.
* Subjects who have received treatment with any non-marketed drug substance (i.e. an agent which has not yet been made available for clinical use following registration) within the 4-week period prior to randomisation or longer, if the class of substance required a longer washout as defined above (e.g. biological treatments).
* Planned excessive exposure to the sun during the study that may affect the psoriasis vulgaris.
* Previously randomised in this study.
* Females who are pregnant, have a positive pregnancy test at Day 0 (Visit 1), or are breast-feeding. Females of child-bearing potential wishing to become pregnant during the study, or not using an adequate method of contraception during the study.

Primary outcomes:
measure: Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4
timeFrame: 4 weeks
measure: Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8
timeFrame: week 8
Secondary outcomes:
measure: Mean Percentage Change in PASI From Baseline to Week 4
timeFrame: Baseline and 4 weeks
measure: Mean Percentage Change in PASI From Baseline to Week 8
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Horizon Research Group, Inc
state: Alabama
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Lomita
country: United States
facility: DBA Torrance Clinical Research
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Walter Nahm, MD, Ph.D., Inc
state: California
city: San Luis Obispo
country: United States
facility: Coastal Medical Research Group, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Santa Monica
country: United States
facility: Dermatology Research Centers
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center, LLC
state: Colorado
city: Boynton Beach
country: United States
facility: Visions Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center
state: Georgia
city: Atlanta
country: United States
facility: Peachtree Dermatology Associates
state: Georgia
city: Macon
country: United States
facility: Dermatologic Surgery Specialists, PC
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc
state: Georgia
city: Arlington Hts
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic, Inc.
state: Indiana
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: Indiana Clinical Trials Center
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Rockville
country: United States
facility: Lawrence J. Green, MD, LLC
state: Maryland
city: Ann Arbor
country: United States
facility: David Fivenson, MD Dermatology, PLC
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc
state: Michigan
city: Clinton Township
country: United States
facility: Michigan Center for Research Corp.,
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Henderson
country: United States
facility: Karl G. Heine, M. D. Dermatology
state: Nevada
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central NJ
state: New Jersey
city: Edison
country: United States
facility: Anderson & Collins Clinical Research, Inc.
state: New Jersey
city: Verona
country: United States
facility: The Dermatology Group, PC
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: New York
country: United States
facility: Mount Sinai School of Medicine
state: New York
city: Stony Brook
country: United States
facility: Derm Research Center of New York
state: New York
city: Cary
country: United States
facility: Triangle Medical Research Associates, LLC
state: North Carolina
city: South Euclid
country: United States
facility: Haber Dermatology and Cosmetic Surgery
state: Ohio
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Johnstown
country: United States
facility: King-Maceyko Dermatology Associates
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: College Station
country: United States
facility: J&S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Division of Dermatology, Baylor Research Institute
state: Texas
city: Houston
country: United States
facility: Centre for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research, P.A.
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: Division of Dermatology, Baylor Research Institute, USA
name: Alan Menter, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Center for Clinical Studies
name: Stephen Tyring, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Clinical Research Center of San Antonio
name: Steven A Davis, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatologic Surgery Specialists
name: David J Cohen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Progressive Clinical Research
name: Mark Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Atlanta Dermatology, Vein & Research Center
name: Tiffani K Hamilton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Michigan Center for Research Corp.
name: Daniel M Stewart, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Palm Beach Research Center
name: John J Goodman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: J&S Studies, Inc
name: Terry Jones, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Burke Pharmaceutical Research
name: Dow Stough, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Psoriasis Treatment Center of Central NJ
name: Jerry Bagel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ameriderm Research
name: James A Solomon, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Somerset Skin Centre
name: George J Murakawa, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Altman Dermatology Associates
name: Michael Bukhalo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deaconess Clinic, Inc.
name: Jeffrey Moore, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peachtree Dermatology Associates Research Center
name: Jaime D Weisman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: North Florida Dermatology Associates
name: Jonathan Kantor, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Associates and Research
name: David Rodriguez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Center, Inc
name: Leonard Swinyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academic Dermatology Associates
name: Alicia Bucko, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gwinnett Clinical Research Center, Inc
name: Johnathan Weiss, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Premier Clinical Research
name: William P Werschler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Mark Lebwohl, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Colorado Medical Research Center, Inc.
name: James Swinehart, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minnesota Clinical Study Center
name: Steve Kempers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skin Surgery Medical Group, Inc.
name: Dale Martin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana Clinical Trials Center
name: Scott Guenthner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dawes Fretzin Clinical Research Group
name: Kenneth Dawes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Glazer Dermatology
name: Scott Glazer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karl G. Heine, M. D. Dermatology
name: Karl G Heine, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamzavi Dermatology
name: Fasahat Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists, Inc.
name: Joseph Samady, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Owensboro Dermatology Associates
name: Artis P Truett III, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Dermatology and Research Center
name: Phoebe Rich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VISIONS CLINICAL RESEARCH
name: Robin Shecter, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Haber Dermatology and Cosmetic Surgery
name: Robert Haber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Horizons Clinical Research Center, LLC
name: David Kerr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: David Fivenson, MD Dermatology, PLC
name: David Fivenson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Walter Nahm, MD, Ph.D., Inc
name: Walter Nahm, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Grekin Skin Institute
name: Steven Grekin, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Specialists
name: Joseph F Fowler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Dermatology Research, Inc.
name: Jose E Mendez, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: Dermatology Research Centers
name: David M Stoll, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Science Institute
name: Paul S Yamauchi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Dermatology Group, PC
name: Robert Nossa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DBA Torrance Clinical Research
name: Chernila Selbert Alan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Great Lakes Research Group, Inc
name: Brent M Boyce, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Clinical Research Institute
name: David B Friedman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: King-Maceyko Dermatology Associates
name: Andrew King, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Triangle Medical Research Associates, LLC
name: Catherine Hren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Derm Research Center of New York
name: Elyse S Rafal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: West Dermatolgy
name: John Siebenlist, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Health System
name: Linda Stein Gold, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh Medical Center
name: Laura K Ferris, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Trials of Texas, Inc.
name: Elizabeth Hughes Tichy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Anderson & Collins Clinical Research, Inc.
name: Jane M Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hudson Dermatology
name: Charles P Hudson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Horizon Research Group, Inc.
name: Amy M Morris, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lawrence J. Green, MD, LLC
name: Lawrence Green, MD
role: PRINCIPAL_INVESTIGATOR
References: