LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

August 9, 2016 updated by: LEO Pharma

A Phase 2 Study Comparing Treatment With LEO 90100 With Calcipotriol Plus Betamethasone Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris.

The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

376

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
    • California
      • Los Angeles, California, United States, 90045
        • Dermatology Research Associates
      • Oceanside, California, United States, 92056
        • Dermatology Specialists, Inc.
      • San Diego, California, United States, 92123
        • University Clinical Trials, Inc.
      • San Diego, California, United States, 92117
        • Skin Surgery Medical Group, Inc
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center
      • Denver, Colorado, United States, 80210
        • Colorado Medical Research Center, Inc
      • Denver, Colorado, United States, 80113
        • About Skin Dermatology and DermSurgery, PC
    • Florida
      • 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
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Gwinnett Clinical Research Ctr, Inc
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Altman Dermatology Associates
      • Buffalo Grove, Illinois, United States, 60089
        • Glazer Dermatology
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Clinical Research Advantage, Inc./Hudson Dermatology, LLC
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Owensboro Dermatology Associates
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • David Fivenson, MD, PLC
      • Bay City, Michigan, United States, 48706
        • Great Lakes Research Group, Inc.
      • Troy, Michigan, United States, 48084
        • Derm Center
      • Warren, Michigan, United States, 48008
        • Grekin Skin Institute
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • New Jersey
      • East Windsor, New Jersey, United States, 08520
        • Psoriasis Treatment Center of Central NJ
      • Verona, New Jersey, United States, 07044
        • The Dermatology Group, PC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106-5239
        • Academic Dermatology Associates
    • New York
      • Stony Brook, New York, United States, 11790
        • Derm Research Center of New York
    • Pennsylvania
      • Fort Washington, Pennsylvania, United States, 19034
        • Philadelphia Institute of Dermatology
    • Texas
      • Dallas, Texas, United States, 75246
        • Menter Dermatology Research Institute
      • Houston, Texas, United States, 77056
        • Suzanne Bruce and Associates, P.A.,The Center for Skin Research
      • Houston, Texas, United States, 77065
        • Center for Clinical Studies
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
      • San Antonio, Texas, United States, 78229
        • Dermatology Clinical Research Center of San Antonio
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc
    • Utah
      • Salt Lake City, Utah, United States, 84117
        • Dermatology Research Center, Inc.
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 washout period).
  • Age 18 years or above
  • Either sex
  • Any race or ethnicity
  • All skin types
  • 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).
  • 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 8 weeks prior to randomisation
    • ustekinumab - within 16 weeks prior to randomisation
    • other products - 4 weeks/5 half-lives (whichever is longer)
  • Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
  • Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
  • PUVA therapy within 4 weeks prior to randomisation.
  • UVB therapy within 2 weeks prior to randomisation.
  • Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.
  • Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, 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, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.
  • Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.
  • 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.
  • Previously randomised in this study.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: LEO 90100 vehicle
Aerosol foam with no active ingredient
Drug: LEO 90100 vehicle
ACTIVE_COMPARATOR: Betamethasone plus calcipotriol
Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
Drug: Betamethasone plus calcipotriol
EXPERIMENTAL: LEO 90100
LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
Drug: LEO 90100
PLACEBO_COMPARATOR: Ointment vehicle
Ointment with no active ingredients
Drug: Ointment vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
Time Frame: 4 weeks
Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Investigators

  • Principal Investigator: John Koo, MD, University of California, San Francisco School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (ESTIMATE)

February 22, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

September 19, 2016

Last Update Submitted That Met QC Criteria

August 9, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEO 90100-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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