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 4Controlled 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 4Mean 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
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