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Trial record 69 of 273 for:    Betamethasone

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

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ClinicalTrials.gov Identifier: NCT01188928
Recruitment Status : Completed
First Posted : August 26, 2010
Results First Posted : April 9, 2013
Last Update Posted : February 2, 2017
Sponsor:
Information provided by (Responsible Party):
LEO Pharma

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).

Condition or disease Intervention/treatment Phase
Psoriasis Vulgaris Drug: Calcipotriol plus betamethasone Drug: Betamethasone-17,21-dipropionate Drug: Calcipotriene Drug: Topical suspension vehicle Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : September 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011


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.




Primary Outcome Measures :
  1. Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4 [ Time Frame: 4 weeks ]
    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.

  2. Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8 [ Time Frame: week 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.


Secondary Outcome Measures :
  1. Mean Percentage Change in PASI From Baseline to Week 4 [ Time Frame: Baseline and 4 weeks ]
    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.

  2. Mean Percentage Change in PASI From Baseline to Week 8 [ Time Frame: Baseline and 8 weeks ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188928


  Show 59 Study Locations
Sponsors and Collaborators
LEO Pharma
Investigators
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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: Daniel M Stewart, DO Michigan Center for Research Corp.
Principal Investigator: John J Goodman, MD Palm Beach Research Center
Principal Investigator: Terry Jones, MD J&S Studies, Inc
Principal Investigator: Dow Stough, MD Burke Pharmaceutical Research
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: Michael Bukhalo, MD Altman Dermatology Associates
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: Mark Lebwohl, MD Icahn School of Medicine at Mount Sinai
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: Fasahat Hamzavi, MD Hamzavi Dermatology
Principal Investigator: Joseph Samady, MD Dermatology Specialists, Inc.
Principal Investigator: Artis P Truett III, MD Owensboro Dermatology Associates
Principal Investigator: Phoebe Rich, MD Oregon Dermatology and Research Center
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: Steven Grekin, DO Grekin Skin Institute
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

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Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01188928     History of Changes
Other Study ID Numbers: LEO 80185-G23
First Posted: August 26, 2010    Key Record Dates
Results First Posted: April 9, 2013
Last Update Posted: February 2, 2017
Last Verified: December 2016
Additional relevant MeSH terms:
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Betamethasone
Betamethasone Valerate
Betamethasone-17,21-dipropionate
Betamethasone benzoate
Betamethasone sodium phosphate
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Calcitriol
Calcipotriene
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Vitamins
Micronutrients
Nutrients
Growth Substances
Bone Density Conservation Agents