LEO 80185 in the Treatment of Psoriasis Vulgaris on the Non-scalp Regions of the Body (Trunk and/or Limbs)

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)

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).

Study Overview

• Status: Completed
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: Calcipotriol plus betamethasone; Drug: Betamethasone-17,21-dipropionate; Drug: Calcipotriene; Drug: Topical suspension vehicle

• Study Type: Interventional
• Enrollment (Actual): 1152
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36606
      • Horizon Research Group, Inc
  • Arkansas
    • Hot Springs, Arkansas, United States, 71913
      • Burke Pharmaceutical Research
  • California
    • Anaheim, California, United States, 92801
      • Advanced Clinical Research Institute
    • Lomita, California, United States, 90717
      • DBA Torrance Clinical Research
    • Oceanside, California, United States, 92056
      • Dermatology Specialists, Inc.
    • San Diego, California, United States, 92117
      • Skin Surgery Medical Group, Inc.
    • San Diego, California, United States, 92123
      • Walter Nahm, MD, Ph.D., Inc
    • San Luis Obispo, California, United States, 93401
      • Coastal Medical Research Group, Inc.
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
    • Santa Monica, California, United States, 90404
      • Dermatology Research Centers
  • Colorado
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
    • Denver, Colorado, United States, 80120
      • Colorado Medical Research Center, Inc.
  • Florida
    • Boynton Beach, Florida, United States, 33472
      • Visions Clinical Research
    • Coral Gables, Florida, United States, 33134
      • Dermatology Associates and Research
    • Jacksonville, Florida, United States, 32204
      • North Florida Dermatology Associates, PA
    • Miami, Florida, United States, 33144
      • International Dermatology Research, Inc.
    • Ormond Beach, Florida, United States, 32174
      • Ameriderm Research
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
  • Georgia
    • Alpharetta, Georgia, United States, 30022
      • Atlanta Dermatology, Vein & Research Center
    • Atlanta, Georgia, United States, 30327
      • Peachtree Dermatology Associates
    • Macon, Georgia, United States, 31217
      • Dermatologic Surgery Specialists, PC
    • Snellville, Georgia, United States, 30078
      • Gwinnett Clinical Research Center, Inc
  • Illinois
    • Arlington Hts, Illinois, United States, 60005
      • Altman Dermatology Associates
    • Buffalo Grove, Illinois, United States, 60089
      • Glazer Dermatology
  • Indiana
    • Evansville, Indiana, United States, 47713
      • Deaconess Clinic, Inc.
    • Evansville, Indiana, United States, 47714
      • Hudson Dermatology
    • Indianapolis, Indiana, United States, 46256
      • Dawes Fretzin Clinical Research Group
    • Plainfield, Indiana, United States, 46168
      • Indiana Clinical Trials Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Dermatology Specialists
    • Owensboro, Kentucky, United States, 42303
      • Owensboro Dermatology Associates
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Lawrence J. Green, MD, LLC
  • Michigan
    • Ann Arbor, Michigan, United States, 48103
      • David Fivenson, MD Dermatology, PLC
    • Bay City, Michigan, United States, 48706
      • Great Lakes Research Group, Inc
    • Clinton Twp, Michigan, United States, 48038
      • Michigan Center for Research Corp.,
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology
    • Troy, Michigan, United States, 48084
      • Somerset Skin Centre
    • Warren, Michigan, United States, 48088
      • Grekin Skin Institute
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Minnesota Clinical Study Center
  • Nevada
    • Henderson, Nevada, United States, 89052
      • Karl G. Heine, M. D. Dermatology
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central NJ
    • Edison, New Jersey, United States, 08817
      • Anderson & Collins Clinical Research, Inc.
    • Verona, New Jersey, United States, 07044
      • The Dermatology Group, PC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • Academic Dermatology Associates
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • Stony Brook, New York, United States, 11790
      • Derm Research Center of New York
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Triangle Medical Research Associates, LLC
  • Ohio
    • South Euclid, Ohio, United States, 44118
      • Haber Dermatology and Cosmetic Surgery
  • Oregon
    • Portland, Oregon, United States, 97210
      • Oregon Dermatology and Research Center
  • Pennsylvania
    • Johnstown, Pennsylvania, United States, 15905
      • King-Maceyko Dermatology Associates
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
    • Dallas, Texas, United States, 75246
      • Division of Dermatology, Baylor Research Institute
    • Houston, Texas, United States, 77030
      • Centre for Clinical Studies
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • San Antonio, Texas, United States, 78229
      • Clinical Trials of Texas, Inc.
    • San Antonio, Texas, United States, 78229
      • Progressive Clinical Research, P.A.
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Dermatology Research Center, Inc.
  • Washington
    • Spokane, Washington, United States, 99204
      • Premier Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 80185; Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension	Drug: Calcipotriol plus betamethasone; Topical suspension once daily for up to 8 weeks.
Active Comparator: Betamethasone; Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle	Drug: Betamethasone-17,21-dipropionate; Topical suspension once daily for up to 8 weeks.
Active Comparator: Calcipotriol; Calcipotriol 50 mcg/g in the topical suspension vehicle	Drug: Calcipotriene; Topical suspension once daily for up to 8 weeks.
Placebo Comparator: Topical suspension vehicle; The topical suspension vehicle alone	Drug: Topical suspension vehicle; Topical suspension once daily for up to 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4	The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.	4 weeks
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8	The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.	week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Percentage Change in PASI From Baseline to Week 4	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.	Baseline and 4 weeks
Mean Percentage Change in PASI From Baseline to Week 8	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Steven Grekin, DO, Grekin Skin Institute; Principal Investigator: Phoebe Rich, MD, Oregon Dermatology and Research Center; Principal Investigator: Dow Stough, MD, Burke Pharmaceutical Research; Principal Investigator: Daniel M Stewart, DO, Michigan Center for Research Corp.; Principal Investigator: Fasahat Hamzavi, MD, Hamzavi Dermatology; Principal Investigator: Alan Menter, MD, Division of Dermatology, Baylor Research Institute, USA; Principal Investigator: Stephen Tyring, MD PhD, Center For Clinical Studies; Principal Investigator: Steven A Davis, MD, Dermatology Clinical Research Center of San Antonio; Principal Investigator: David J Cohen, MD, Dermatologic Surgery Specialists; Principal Investigator: Mark Lee, MD, Progressive Clinical Research; Principal Investigator: Tiffani K Hamilton, MD, Atlanta Dermatology, Vein & Research Center; Principal Investigator: John J Goodman, MD, Palm Beach Research Center; Principal Investigator: Terry Jones, MD, J&S Studies, Inc; Principal Investigator: Jerry Bagel, MD, Psoriasis Treatment Center of Central NJ; Principal Investigator: James A Solomon, MD PhD, Ameriderm Research; Principal Investigator: George J Murakawa, MD PhD, Somerset Skin Centre; Principal Investigator: Jeffrey Moore, MD, Deaconess Clinic, Inc.; Principal Investigator: Jaime D Weisman, MD, Peachtree Dermatology Associates Research Center; Principal Investigator: Jonathan Kantor, MD, North Florida Dermatology Associates; Principal Investigator: David Rodriguez, MD, Dermatology Associates and Research; Principal Investigator: Leonard Swinyer, MD, Dermatology Research Center, Inc; Principal Investigator: Alicia Bucko, MD, Academic Dermatology Associates; Principal Investigator: Johnathan Weiss, MD, Gwinnett Clinical Research Center, Inc; Principal Investigator: William P Werschler, MD, Premier Clinical Research; Principal Investigator: James Swinehart, MD, Colorado Medical Research Center, Inc.; Principal Investigator: Steve Kempers, MD, Minnesota Clinical Study Center; Principal Investigator: Dale Martin, MD, Skin Surgery Medical Group, Inc.; Principal Investigator: Scott Guenthner, MD, Indiana Clinical Trials Center; Principal Investigator: Kenneth Dawes, MD, Dawes Fretzin Clinical Research Group; Principal Investigator: Scott Glazer, MD, Glazer Dermatology; Principal Investigator: Karl G Heine, MD, Karl G. Heine, M. D. Dermatology; Principal Investigator: Joseph Samady, MD, Dermatology Specialists, Inc.; Principal Investigator: Artis P Truett III, MD, Owensboro Dermatology Associates; Principal Investigator: Robin Shecter, DO, Visions Clinical Research; Principal Investigator: Robert Haber, MD, Haber Dermatology and Cosmetic Surgery; Principal Investigator: David Kerr, MD, Horizons Clinical Research Center, LLC; Principal Investigator: David Fivenson, MD, David Fivenson, MD Dermatology, PLC; Principal Investigator: Walter Nahm, MD PhD, Walter Nahm, MD, Ph.D., Inc; Principal Investigator: Joseph F Fowler, MD, Dermatology Specialists; Principal Investigator: Jose E Mendez, DO, International Dermatology Research, Inc.; Principal Investigator: David M Stoll, MD, Dermatology Research Centers; Principal Investigator: Paul S Yamauchi, MD, Clinical Science Institute; Principal Investigator: Robert Nossa, MD, The Dermatology Group, PC; Principal Investigator: Chernila Selbert Alan, MD, DBA Torrance Clinical Research; Principal Investigator: Brent M Boyce, MD, Great Lakes Research Group, Inc; Principal Investigator: David B Friedman, MD, Advanced Clinical Research Institute; Principal Investigator: Andrew King, MD, King-Maceyko Dermatology Associates; Principal Investigator: Catherine Hren, MD, Triangle Medical Research Associates, LLC; Principal Investigator: Elyse S Rafal, MD, Derm Research Center of New York; Principal Investigator: John Siebenlist, MD, West Dermatolgy; Principal Investigator: Linda Stein Gold, MD, Henry Ford Health System; Principal Investigator: Laura K Ferris, MD PhD, University of Pittsburgh Medical Center; Principal Investigator: Elizabeth Hughes Tichy, MD, Clinical Trials of Texas, Inc.; Principal Investigator: Jane M Lee, MD, Anderson & Collins Clinical Research, Inc.; Principal Investigator: Charles P Hudson, MD, Hudson Dermatology; Principal Investigator: Amy M Morris, MD, Horizon Research Group, Inc.; Principal Investigator: Lawrence Green, MD, Lawrence J. Green, MD, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: August 25, 2010
• First Submitted That Met QC Criteria: August 25, 2010
• First Posted (Estimate): August 26, 2010

Study Record Updates

• Last Update Posted (Estimate): February 2, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Anti-Asthmatic Agents; Respiratory System Agents; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Calcipotriene; Betamethasone sodium phosphate
• Other Study ID Numbers: LEO 80185-G23