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

NCT ID: NCT01188928

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-03-31

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).

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LEO 80185

Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension

Group Type: EXPERIMENTAL

Calcipotriol plus betamethasone

Intervention Type: DRUG

Topical suspension once daily for up to 8 weeks.

Betamethasone

Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle

Group Type: ACTIVE_COMPARATOR

Betamethasone-17,21-dipropionate

Intervention Type: DRUG

Topical suspension once daily for up to 8 weeks.

Calcipotriol

Calcipotriol 50 mcg/g in the topical suspension vehicle

Group Type: ACTIVE_COMPARATOR

Calcipotriene

Intervention Type: DRUG

Topical suspension once daily for up to 8 weeks.

Topical suspension vehicle

The topical suspension vehicle alone

Group Type: PLACEBO_COMPARATOR

Topical suspension vehicle

Intervention Type: DRUG

Topical suspension once daily for up to 8 weeks.

Interventions

Calcipotriol plus betamethasone

Topical suspension once daily for up to 8 weeks.

Intervention Type: DRUG

Betamethasone-17,21-dipropionate

Topical suspension once daily for up to 8 weeks.

Intervention Type: DRUG

Calcipotriene

Topical suspension once daily for up to 8 weeks.

Intervention Type: DRUG

Topical suspension vehicle

Topical suspension once daily for up to 8 weeks.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alan Menter, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Dermatology, Baylor Research Institute, USA

Stephen Tyring, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Center for Clinical Studies

Steven A Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Clinical Research Center of San Antonio

David J Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatologic Surgery Specialists

Mark Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Progressive Clinical Research

Tiffani K Hamilton, MD

Role: PRINCIPAL_INVESTIGATOR

Atlanta Dermatology, Vein & Research Center

Daniel M Stewart, DO

Role: PRINCIPAL_INVESTIGATOR

Michigan Center for Research Corp.

John J Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

Palm Beach Research Center

Terry Jones, MD

Role: PRINCIPAL_INVESTIGATOR

J&S Studies, Inc

Dow Stough, MD

Role: PRINCIPAL_INVESTIGATOR

Burke Pharmaceutical Research

Jerry Bagel, MD

Role: PRINCIPAL_INVESTIGATOR

Psoriasis Treatment Center of Central NJ

James A Solomon, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Ameriderm Research

George J Murakawa, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Somerset Skin Centre

Michael Bukhalo, MD

Role: PRINCIPAL_INVESTIGATOR

Altman Dermatology Associates

Jeffrey Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Deaconess Clinic, Inc.

Jaime D Weisman, MD

Role: PRINCIPAL_INVESTIGATOR

Peachtree Dermatology Associates Research Center

Jonathan Kantor, MD

Role: PRINCIPAL_INVESTIGATOR

North Florida Dermatology Associates

David Rodriguez, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Associates and Research

Leonard Swinyer, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Research Center, Inc

Alicia Bucko, MD

Role: PRINCIPAL_INVESTIGATOR

Academic Dermatology Associates

Johnathan Weiss, MD

Role: PRINCIPAL_INVESTIGATOR

Gwinnett Clinical Research Center, Inc

William P Werschler, MD

Role: PRINCIPAL_INVESTIGATOR

Premier Clinical Research

Mark Lebwohl, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

James Swinehart, MD

Role: PRINCIPAL_INVESTIGATOR

Colorado Medical Research Center, Inc.

Steve Kempers, MD

Role: PRINCIPAL_INVESTIGATOR

Minnesota Clinical Study Center

Dale Martin, MD

Role: PRINCIPAL_INVESTIGATOR

Skin Surgery Medical Group, Inc.

Scott Guenthner, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana Clinical Trials Center

Kenneth Dawes, MD

Role: PRINCIPAL_INVESTIGATOR

Dawes Fretzin Clinical Research Group

Scott Glazer, MD

Role: PRINCIPAL_INVESTIGATOR

Glazer Dermatology

Karl G Heine, MD

Role: PRINCIPAL_INVESTIGATOR

Karl G. Heine, M. D. Dermatology

Fasahat Hamzavi, MD

Role: PRINCIPAL_INVESTIGATOR

Hamzavi Dermatology

Joseph Samady, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists, Inc.

Artis P Truett III, MD

Role: PRINCIPAL_INVESTIGATOR

Owensboro Dermatology Associates

Phoebe Rich, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Dermatology and Research Center

Robin Shecter, DO

Role: PRINCIPAL_INVESTIGATOR

VISIONS CLINICAL RESEARCH

Robert Haber, MD

Role: PRINCIPAL_INVESTIGATOR

Haber Dermatology and Cosmetic Surgery

David Kerr, MD

Role: PRINCIPAL_INVESTIGATOR

Horizons Clinical Research Center, LLC

David Fivenson, MD

Role: PRINCIPAL_INVESTIGATOR

David Fivenson, MD Dermatology, PLC

Walter Nahm, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Walter Nahm, MD, Ph.D., Inc

Steven Grekin, DO

Role: PRINCIPAL_INVESTIGATOR

Grekin Skin Institute

Joseph F Fowler, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Specialists

Jose E Mendez, DO

Role: PRINCIPAL_INVESTIGATOR

International Dermatology Research, Inc.

David M Stoll, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Research Centers

Paul S Yamauchi, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Science Institute

Robert Nossa, MD

Role: PRINCIPAL_INVESTIGATOR

The Dermatology Group, PC

Chernila Selbert Alan, MD

Role: PRINCIPAL_INVESTIGATOR

DBA Torrance Clinical Research

Brent M Boyce, MD

Role: PRINCIPAL_INVESTIGATOR

Great Lakes Research Group, Inc

David B Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Clinical Research Institute

Andrew King, MD

Role: PRINCIPAL_INVESTIGATOR

King-Maceyko Dermatology Associates

Catherine Hren, MD

Role: PRINCIPAL_INVESTIGATOR

Triangle Medical Research Associates, LLC

Elyse S Rafal, MD

Role: PRINCIPAL_INVESTIGATOR

Derm Research Center of New York

John Siebenlist, MD

Role: PRINCIPAL_INVESTIGATOR

West Dermatolgy

Linda Stein Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Laura K Ferris, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh Medical Center

Elizabeth Hughes Tichy, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Trials of Texas, Inc.

Jane M Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Anderson & Collins Clinical Research, Inc.

Charles P Hudson, MD

Role: PRINCIPAL_INVESTIGATOR

Hudson Dermatology

Amy M Morris, MD

Role: PRINCIPAL_INVESTIGATOR

Horizon Research Group, Inc.

Lawrence Green, MD

Role: PRINCIPAL_INVESTIGATOR

Lawrence J. Green, MD, LLC

Locations

Horizon Research Group, Inc

Mobile, Alabama, United States

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Advanced Clinical Research Institute

Anaheim, California, United States

DBA Torrance Clinical Research

Lomita, California, United States

Dermatology Specialists, Inc.

Oceanside, California, United States

Skin Surgery Medical Group, Inc.

San Diego, California, United States

Walter Nahm, MD, Ph.D., Inc

San Diego, California, United States

Coastal Medical Research Group, Inc.

San Luis Obispo, California, United States

Clinical Science Institute

Santa Monica, California, United States

Dermatology Research Centers

Santa Monica, California, United States

Colorado Medical Research Center, Inc.

Denver, Colorado, United States

Horizons Clinical Research Center, LLC

Denver, Colorado, United States

Visions Clinical Research

Boynton Beach, Florida, United States

Dermatology Associates and Research

Coral Gables, Florida, United States

North Florida Dermatology Associates, PA

Jacksonville, Florida, United States

International Dermatology Research, Inc.

Miami, Florida, United States

Ameriderm Research

Ormond Beach, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, United States

Peachtree Dermatology Associates

Atlanta, Georgia, United States

Dermatologic Surgery Specialists, PC

Macon, Georgia, United States

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, United States

Altman Dermatology Associates

Arlington Hts, Illinois, United States

Glazer Dermatology

Buffalo Grove, Illinois, United States

Deaconess Clinic, Inc.

Evansville, Indiana, United States

Hudson Dermatology

Evansville, Indiana, United States

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, United States

Indiana Clinical Trials Center

Plainfield, Indiana, United States

Dermatology Specialists

Louisville, Kentucky, United States

Owensboro Dermatology Associates

Owensboro, Kentucky, United States

Lawrence J. Green, MD, LLC

Rockville, Maryland, United States

David Fivenson, MD Dermatology, PLC

Ann Arbor, Michigan, United States

Great Lakes Research Group, Inc

Bay City, Michigan, United States

Michigan Center for Research Corp.,

Clinton Township, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Somerset Skin Centre

Troy, Michigan, United States

Grekin Skin Institute

Warren, Michigan, United States

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Karl G. Heine, M. D. Dermatology

Henderson, Nevada, United States

Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, United States

Anderson & Collins Clinical Research, Inc.

Edison, New Jersey, United States

The Dermatology Group, PC

Verona, New Jersey, United States

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Mount Sinai School of Medicine

New York, New York, United States

Derm Research Center of New York

Stony Brook, New York, United States

Triangle Medical Research Associates, LLC

Cary, North Carolina, United States

Haber Dermatology and Cosmetic Surgery

South Euclid, Ohio, United States

Oregon Dermatology and Research Center

Portland, Oregon, United States

King-Maceyko Dermatology Associates

Johnstown, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

J&S Studies, Inc.

College Station, Texas, United States

Division of Dermatology, Baylor Research Institute

Dallas, Texas, United States

Centre for Clinical Studies

Houston, Texas, United States

Clinical Trials of Texas, Inc.

San Antonio, Texas, United States

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, United States

Progressive Clinical Research, P.A.

San Antonio, Texas, United States

Dermatology Research Center, Inc.

Salt Lake City, Utah, United States

Premier Clinical Research

Spokane, Washington, United States

Countries

United States

Related Links

https://www.leopharmatrials.com/en

Clinical Trials at LEO Pharma

Other Identifiers

LEO 80185-G23

Identifier Type: -

Identifier Source: org_study_id