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

Information source: LEO Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Psoriasis Vulgaris

Intervention: Calcipotriol plus betamethasone (Drug); Betamethasone-17,21-dipropionate (Drug); Calcipotriene (Drug); Topical suspension vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: LEO Pharma

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

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).

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4

Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8

Secondary outcome:

Mean Percentage Change in PASI From Baseline to Week 4

Mean Percentage Change in PASI From Baseline to Week 8

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Horizon Research Group, Inc, Mobile, Alabama 36606, United States

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States

Advanced Clinical Research Institute, Anaheim, California 92801, United States

DBA Torrance Clinical Research, Lomita, California 90717, United States

Dermatology Specialists, Inc., Oceanside, California 92056, United States

Skin Surgery Medical Group, Inc., San Diego, California 92117, United States

Walter Nahm, MD, Ph.D., Inc, San Diego, California 92123, United States

Coastal Medical Research Group, Inc., San Luis Obispo, California 93401, United States

Clinical Science Institute, Santa Monica, California 90404, United States

Dermatology Research Centers, Santa Monica, California 90404, United States

Colorado Medical Research Center, Inc., Denver, Colorado 80120, United States

Horizons Clinical Research Center, LLC, Denver, Colorado 80220, United States

Visions Clinical Research, Boynton Beach, Florida 33472, United States

Dermatology Associates and Research, Coral Gables, Florida 33134, United States

North Florida Dermatology Associates, PA, Jacksonville, Florida 32204, United States

International Dermatology Research, Inc., Miami, Florida 33144, United States

Ameriderm Research, Ormond Beach, Florida 32174, United States

Palm Beach Research Center, West Palm Beach, Florida 33409, United States

Atlanta Dermatology, Vein & Research Center, Alpharetta, Georgia 30022, United States

Peachtree Dermatology Associates, Atlanta, Georgia 30327, United States

Dermatologic Surgery Specialists, PC, Macon, Georgia 31217, United States

Gwinnett Clinical Research Center, Inc, Snellville, Georgia 30078, United States

Altman Dermatology Associates, Arlington Hts, Illinois 60005, United States

Glazer Dermatology, Buffalo Grove, Illinois 60089, United States

Deaconess Clinic, Inc., Evansville, Indiana 47713, United States

Hudson Dermatology, Evansville, Indiana 47714, United States

Dawes Fretzin Clinical Research Group, Indianapolis, Indiana 46256, United States

Indiana Clinical Trials Center, Plainfield, Indiana 46168, United States

Dermatology Specialists, Louisville, Kentucky 40202, United States

Owensboro Dermatology Associates, Owensboro, Kentucky 42303, United States

Lawrence J. Green, MD, LLC, Rockville, Maryland 20850, United States

David Fivenson, MD Dermatology, PLC, Ann Arbor, Michigan 48103, United States

Great Lakes Research Group, Inc, Bay City, Michigan 48706, United States

Michigan Center for Research Corp.,, Clinton Twp, Michigan 48038, United States

Henry Ford Health System, Detroit, Michigan 48202, United States

Hamzavi Dermatology, Fort Gratiot, Michigan 48059, United States

Somerset Skin Centre, Troy, Michigan 48084, United States

Grekin Skin Institute, Warren, Michigan 48088, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Karl G. Heine, M. D. Dermatology, Henderson, Nevada 89052, United States

Psoriasis Treatment Center of Central NJ, East Windsor, New Jersey 08520, United States

Anderson & Collins Clinical Research, Inc., Edison, New Jersey 08817, United States

The Dermatology Group, PC, Verona, New Jersey 07044, United States

Academic Dermatology Associates, Albuquerque, New Mexico 87106, United States

Mount Sinai School of Medicine, New York, New York 10029, United States

Derm Research Center of New York, Stony Brook, New York 11790, United States

Triangle Medical Research Associates, LLC, Cary, North Carolina 27518, United States

Haber Dermatology and Cosmetic Surgery, South Euclid, Ohio 44118, United States

Oregon Dermatology and Research Center, Portland, Oregon 97210, United States

King-Maceyko Dermatology Associates, Johnstown, Pennsylvania 15905, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

J&S Studies, Inc., College Station, Texas 77845, United States

Division of Dermatology, Baylor Research Institute, Dallas, Texas 75246, United States

Centre for Clinical Studies, Houston, Texas 77030, United States

Clinical Trials of Texas, Inc., San Antonio, Texas 78229, United States

Dermatology Clinical Research Center of San Antonio, San Antonio, Texas 78229, United States

Progressive Clinical Research, P.A., San Antonio, Texas 78229, United States

Dermatology Research Center, Inc., Salt Lake City, Utah 84117, United States

Premier Clinical Research, Spokane, Washington 99204, United States

Additional Information

Clinical Trials at LEO Pharma

Starting date: September 2010
Last updated: March 25, 2015

Page last updated: August 23, 2015

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