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

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).

Conditions

• Psoriasis Vulgaris

Interventions

DRUG

Calcipotriol plus betamethasone

Topical suspension once daily for up to 8 weeks.

DRUG

Betamethasone-17,21-dipropionate

Topical suspension once daily for up to 8 weeks.

DRUG

Calcipotriene

Topical suspension once daily for up to 8 weeks.

DRUG

Topical suspension vehicle

Topical suspension once daily for up to 8 weeks.

Sponsors & Collaborators

• LEO Pharma

  lead INDUSTRY

Principal Investigators

• Alan Menter, MD · Division of Dermatology, Baylor Research Institute, USA

• Stephen Tyring, MD PhD · Center for Clinical Studies

• Steven A Davis, MD · Dermatology Clinical Research Center of San Antonio

• David J Cohen, MD · Dermatologic Surgery Specialists

• Mark Lee, MD · Progressive Clinical Research

• Tiffani K Hamilton, MD · Atlanta Dermatology, Vein & Research Center

• Daniel M Stewart, DO · Michigan Center for Research Corp.

• John J Goodman, MD · Palm Beach Research Center

• Terry Jones, MD · J&S Studies, Inc

• Dow Stough, MD · Burke Pharmaceutical Research

• Jerry Bagel, MD · Psoriasis Treatment Center of Central NJ

• James A Solomon, MD PhD · Ameriderm Research

• George J Murakawa, MD PhD · Somerset Skin Centre

• Michael Bukhalo, MD · Altman Dermatology Associates

• Jeffrey Moore, MD · Deaconess Clinic, Inc.

• Jaime D Weisman, MD · Peachtree Dermatology Associates Research Center

• Jonathan Kantor, MD · North Florida Dermatology Associates

• David Rodriguez, MD · Dermatology Associates and Research

• Leonard Swinyer, MD · Dermatology Research Center, Inc

• Alicia Bucko, MD · Academic Dermatology Associates

• Johnathan Weiss, MD · Gwinnett Clinical Research Center, Inc

• William P Werschler, MD · Premier Clinical Research

• Mark Lebwohl, MD · Icahn School of Medicine at Mount Sinai

• James Swinehart, MD · Colorado Medical Research Center, Inc.

• Steve Kempers, MD · Minnesota Clinical Study Center

• Dale Martin, MD · Skin Surgery Medical Group, Inc.

• Scott Guenthner, MD · Indiana Clinical Trials Center

• Kenneth Dawes, MD · Dawes Fretzin Clinical Research Group

• Scott Glazer, MD · Glazer Dermatology

• Karl G Heine, MD · Karl G. Heine, M. D. Dermatology

• Fasahat Hamzavi, MD · Hamzavi Dermatology

• Joseph Samady, MD · Dermatology Specialists, Inc.

• Artis P Truett III, MD · Owensboro Dermatology Associates

• Phoebe Rich, MD · Oregon Dermatology and Research Center

• Robin Shecter, DO · VISIONS CLINICAL RESEARCH

• Robert Haber, MD · Haber Dermatology and Cosmetic Surgery

• David Kerr, MD · Horizons Clinical Research Center, LLC

• David Fivenson, MD · David Fivenson, MD Dermatology, PLC

• Walter Nahm, MD PhD · Walter Nahm, MD, Ph.D., Inc

• Steven Grekin, DO · Grekin Skin Institute

• Joseph F Fowler, MD · Dermatology Specialists

• Jose E Mendez, DO · International Dermatology Research, Inc.

• David M Stoll, MD · Dermatology Research Centers

• Paul S Yamauchi, MD · Clinical Science Institute

• Robert Nossa, MD · The Dermatology Group, PC

• Chernila Selbert Alan, MD · DBA Torrance Clinical Research

• Brent M Boyce, MD · Great Lakes Research Group, Inc

• David B Friedman, MD · Advanced Clinical Research Institute

• Andrew King, MD · King-Maceyko Dermatology Associates

• Catherine Hren, MD · Triangle Medical Research Associates, LLC

• Elyse S Rafal, MD · Derm Research Center of New York

• John Siebenlist, MD · West Dermatolgy

• Linda Stein Gold, MD · Henry Ford Health System

• Laura K Ferris, MD PhD · University of Pittsburgh Medical Center

• Elizabeth Hughes Tichy, MD · Clinical Trials of Texas, Inc.

• Jane M Lee, MD · Anderson & Collins Clinical Research, Inc.

• Charles P Hudson, MD · Hudson Dermatology

• Amy M Morris, MD · Horizon Research Group, Inc.

• Lawrence Green, MD · Lawrence J. Green, MD, LLC

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-09-30

Primary Completion

2011-03-31

Completion

2011-03-31

Countries

• United States

Study Locations