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

NCT01188928 | Completed Phase 3 Results

• 1 other identifier: LEO 80185-G23
• Study Type: interventional
• Target: 1,152
• Locations: 1 country
• Sites: 59

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

Outcome Measures

Primary Outcomes (2)

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

  The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

  4 weeks

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

  The IGA was chosen as the primary efficacy assessment. The primary endpoint is subjects with 'Controlled disease' according to the IGA. 'Controlled disease' is defined as clear or almost clear for subjects with moderate disease at baseline and clear for subjects with mild disease at baseline.

  week 8

Secondary Outcomes (2)

• Mean Percentage Change in PASI From Baseline to Week 4

  Baseline and 4 weeks

• Mean Percentage Change in PASI From Baseline to Week 8

  Baseline and 8 weeks

Study Arms (4)

LEO 80185

EXPERIMENTAL

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

Drug: Calcipotriol plus betamethasone

Betamethasone

ACTIVE COMPARATOR

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

Drug: Betamethasone-17,21-dipropionate

Calcipotriol

ACTIVE COMPARATOR

Calcipotriol 50 mcg/g in the topical suspension vehicle

Drug: Calcipotriene

Topical suspension vehicle

PLACEBO COMPARATOR

The topical suspension vehicle alone

Drug: Topical suspension vehicle

Interventions

Calcipotriol plus betamethasone DRUG

Topical suspension once daily for up to 8 weeks.

LEO 80185

Betamethasone-17,21-dipropionate DRUG

Topical suspension once daily for up to 8 weeks.

Betamethasone

Calcipotriene DRUG

Topical suspension once daily for up to 8 weeks.

Calcipotriol

Topical suspension vehicle DRUG

Topical suspension once daily for up to 8 weeks.

Topical suspension vehicle

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (59)

Horizon Research Group, Inc

Mobile, Alabama, 36606, United States

Location

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Advanced Clinical Research Institute

Anaheim, California, 92801, United States

Location

DBA Torrance Clinical Research

Lomita, California, 90717, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

Skin Surgery Medical Group, Inc.

San Diego, California, 92117, United States

Location

Walter Nahm, MD, Ph.D., Inc

San Diego, California, 92123, United States

Location

Coastal Medical Research Group, Inc.

San Luis Obispo, California, 93401, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Dermatology Research Centers

Santa Monica, California, 90404, United States

Location

Colorado Medical Research Center, Inc.

Denver, Colorado, 80120, United States

Location

Horizons Clinical Research Center, LLC

Denver, Colorado, 80220, United States

Location

Visions Clinical Research

Boynton Beach, Florida, 33472, United States

Location

Dermatology Associates and Research

Coral Gables, Florida, 33134, United States

Location

North Florida Dermatology Associates, PA

Jacksonville, Florida, 32204, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Ameriderm Research

Ormond Beach, Florida, 32174, United States

Location

Palm Beach Research Center

West Palm Beach, Florida, 33409, United States

Location

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, 30022, United States

Location

Peachtree Dermatology Associates

Atlanta, Georgia, 30327, United States

Location

Dermatologic Surgery Specialists, PC

Macon, Georgia, 31217, United States

Location

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, 30078, United States

Location

Altman Dermatology Associates

Arlington Hts, Illinois, 60005, United States

Location

Glazer Dermatology

Buffalo Grove, Illinois, 60089, United States

Location

Deaconess Clinic, Inc.

Evansville, Indiana, 47713, United States

Location

Hudson Dermatology

Evansville, Indiana, 47714, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Dermatology Specialists

Louisville, Kentucky, 40202, United States

Location

Owensboro Dermatology Associates

Owensboro, Kentucky, 42303, United States

Location

Lawrence J. Green, MD, LLC

Rockville, Maryland, 20850, United States

Location

David Fivenson, MD Dermatology, PLC

Ann Arbor, Michigan, 48103, United States

Location

Great Lakes Research Group, Inc

Bay City, Michigan, 48706, United States

Location

Michigan Center for Research Corp.,

Clinton Township, Michigan, 48038, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Hamzavi Dermatology

Fort Gratiot, Michigan, 48059, United States

Location

Somerset Skin Centre

Troy, Michigan, 48084, United States

Location

Grekin Skin Institute

Warren, Michigan, 48088, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Karl G. Heine, M. D. Dermatology

Henderson, Nevada, 89052, United States

Location

Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, 08520, United States

Location

Anderson & Collins Clinical Research, Inc.

Edison, New Jersey, 08817, United States

Location

The Dermatology Group, PC

Verona, New Jersey, 07044, United States

Location

Academic Dermatology Associates

Albuquerque, New Mexico, 87106, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Derm Research Center of New York

Stony Brook, New York, 11790, United States

Location

Triangle Medical Research Associates, LLC

Cary, North Carolina, 27518, United States

Location

Haber Dermatology and Cosmetic Surgery

South Euclid, Ohio, 44118, United States

Location

Oregon Dermatology and Research Center

Portland, Oregon, 97210, United States

Location

King-Maceyko Dermatology Associates

Johnstown, Pennsylvania, 15905, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

J&S Studies, Inc.

College Station, Texas, 77845, United States

Location

Division of Dermatology, Baylor Research Institute

Dallas, Texas, 75246, United States

Location

Centre for Clinical Studies

Houston, Texas, 77030, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research, P.A.

San Antonio, Texas, 78229, United States

Location

Dermatology Research Center, Inc.

Salt Lake City, Utah, 84117, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene; Betamethasone; betamethasone-17,21-dipropionate; Suspensions

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: Leo Pharma A/S

disclosure@leo-pharma.com

+45 4494 5888

Study Officials

• Alan Menter, MD

  Division of Dermatology, Baylor Research Institute, USA

  PRINCIPAL INVESTIGATOR

• Stephen Tyring, MD PhD

  Center for Clinical Studies

  PRINCIPAL INVESTIGATOR

• Steven A Davis, MD

  Dermatology Clinical Research Center of San Antonio

  PRINCIPAL INVESTIGATOR

• David J Cohen, MD

  Dermatologic Surgery Specialists

  PRINCIPAL INVESTIGATOR

• Mark Lee, MD

  Progressive Clinical Research

  PRINCIPAL INVESTIGATOR

• Tiffani K Hamilton, MD

  Atlanta Dermatology, Vein & Research Center

  PRINCIPAL INVESTIGATOR

• Daniel M Stewart, DO

  Michigan Center for Research Corp.

  PRINCIPAL INVESTIGATOR

• John J Goodman, MD

  Palm Beach Research Center

  PRINCIPAL INVESTIGATOR

• Terry Jones, MD

  J&S Studies, Inc

  PRINCIPAL INVESTIGATOR

• Dow Stough, MD

  Burke Pharmaceutical Research

  PRINCIPAL INVESTIGATOR

• Jerry Bagel, MD

  Psoriasis Treatment Center of Central NJ

  PRINCIPAL INVESTIGATOR

• James A Solomon, MD PhD

  Ameriderm Research

  PRINCIPAL INVESTIGATOR

• George J Murakawa, MD PhD

  Somerset Skin Centre

  PRINCIPAL INVESTIGATOR

• Michael Bukhalo, MD

  Altman Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Jeffrey Moore, MD

  Deaconess Clinic, Inc.

  PRINCIPAL INVESTIGATOR

• Jaime D Weisman, MD

  Peachtree Dermatology Associates Research Center

  PRINCIPAL INVESTIGATOR

• Jonathan Kantor, MD

  North Florida Dermatology Associates

  PRINCIPAL INVESTIGATOR

• David Rodriguez, MD

  Dermatology Associates and Research

  PRINCIPAL INVESTIGATOR

• Leonard Swinyer, MD

  Dermatology Research Center, Inc

  PRINCIPAL INVESTIGATOR

• Alicia Bucko, MD

  Academic Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Johnathan Weiss, MD

  Gwinnett Clinical Research Center, Inc

  PRINCIPAL INVESTIGATOR

• William P Werschler, MD

  Premier Clinical Research

  PRINCIPAL INVESTIGATOR

• Mark Lebwohl, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• James Swinehart, MD

  Colorado Medical Research Center, Inc.

  PRINCIPAL INVESTIGATOR

• Steve Kempers, MD

  Minnesota Clinical Study Center

  PRINCIPAL INVESTIGATOR

• Dale Martin, MD

  Skin Surgery Medical Group, Inc.

  PRINCIPAL INVESTIGATOR

• Scott Guenthner, MD

  Indiana Clinical Trials Center

  PRINCIPAL INVESTIGATOR

• Kenneth Dawes, MD

  Dawes Fretzin Clinical Research Group

  PRINCIPAL INVESTIGATOR

• Scott Glazer, MD

  Glazer Dermatology

  PRINCIPAL INVESTIGATOR

• Karl G Heine, MD

  Karl G. Heine, M. D. Dermatology

  PRINCIPAL INVESTIGATOR

• Fasahat Hamzavi, MD

  Hamzavi Dermatology

  PRINCIPAL INVESTIGATOR

• Joseph Samady, MD

  Dermatology Specialists, Inc.

  PRINCIPAL INVESTIGATOR

• Artis P Truett III, MD

  Owensboro Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Phoebe Rich, MD

  Oregon Dermatology and Research Center

  PRINCIPAL INVESTIGATOR

• Robin Shecter, DO

  VISIONS CLINICAL RESEARCH

  PRINCIPAL INVESTIGATOR

• Robert Haber, MD

  Haber Dermatology and Cosmetic Surgery

  PRINCIPAL INVESTIGATOR

• David Kerr, MD

  Horizons Clinical Research Center, LLC

  PRINCIPAL INVESTIGATOR

• David Fivenson, MD

  David Fivenson, MD Dermatology, PLC

  PRINCIPAL INVESTIGATOR

• Walter Nahm, MD PhD

  Walter Nahm, MD, Ph.D., Inc

  PRINCIPAL INVESTIGATOR

• Steven Grekin, DO

  Grekin Skin Institute

  PRINCIPAL INVESTIGATOR

• Joseph F Fowler, MD

  Dermatology Specialists

  PRINCIPAL INVESTIGATOR

• Jose E Mendez, DO

  International Dermatology Research, Inc.

  PRINCIPAL INVESTIGATOR

• David M Stoll, MD

  Dermatology Research Centers

  PRINCIPAL INVESTIGATOR

• Paul S Yamauchi, MD

  Clinical Science Institute

  PRINCIPAL INVESTIGATOR

• Robert Nossa, MD

  The Dermatology Group, PC

  PRINCIPAL INVESTIGATOR

• Chernila Selbert Alan, MD

  DBA Torrance Clinical Research

  PRINCIPAL INVESTIGATOR

• Brent M Boyce, MD

  Great Lakes Research Group, Inc

  PRINCIPAL INVESTIGATOR

• David B Friedman, MD

  Advanced Clinical Research Institute

  PRINCIPAL INVESTIGATOR

• Andrew King, MD

  King-Maceyko Dermatology Associates

  PRINCIPAL INVESTIGATOR

• Catherine Hren, MD

  Triangle Medical Research Associates, LLC

  PRINCIPAL INVESTIGATOR

• Elyse S Rafal, MD

  Derm Research Center of New York

  PRINCIPAL INVESTIGATOR

• John Siebenlist, MD

  West Dermatolgy

  PRINCIPAL INVESTIGATOR

• Linda Stein Gold, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Laura K Ferris, MD PhD

  University of Pittsburgh Medical Center

  PRINCIPAL INVESTIGATOR

• Elizabeth Hughes Tichy, MD

  Clinical Trials of Texas, Inc.

  PRINCIPAL INVESTIGATOR

• Jane M Lee, MD

  Anderson & Collins Clinical Research, Inc.

  PRINCIPAL INVESTIGATOR

• Charles P Hudson, MD

  Hudson Dermatology

  PRINCIPAL INVESTIGATOR

• Amy M Morris, MD

  Horizon Research Group, Inc.

  PRINCIPAL INVESTIGATOR

• Lawrence Green, MD

  Lawrence J. Green, MD, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 26, 2010
• Study Start: September 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: March 10, 2025
• Results First Posted: April 9, 2013

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (59)