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

Phase 3

Completed

Conditions: Psoriasis Vulgaris

Interventions: Drug: Calcipotriol plus betamethasone
Drug: Topical suspension vehicle
Drug: Betamethasone-17,21-dipropionate
Drug: Calcipotriene

Registration Number: NCT01188928

Lead Sponsor: LEO Pharma

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1152

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LEO 80185	Calcipotriol plus betamethasone	Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
Topical suspension vehicle	Topical suspension vehicle	The topical suspension vehicle alone
Betamethasone	Betamethasone-17,21-dipropionate	Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
Calcipotriol	Calcipotriene	Calcipotriol 50 mcg/g in the topical suspension vehicle

Primary Outcome Measures

Name	Time	Method
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 8	week 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.
Controlled Disease According to the Investigator's Global Assessment of Disease Severity (IGA) at Weeks 4	4 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Mean Percentage Change in PASI From Baseline to Week 4	Baseline and 4 weeks	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.
Mean Percentage Change in PASI From Baseline to Week 8	Baseline and 8 weeks	At all treatment phase visits the (sub)investigator made an assessment of the extent and severity of clinical signs of the subject's psoriasis using a modified PASI score (Psoriasis Area and Severity Index) To make up the score, the three features of a psoriatic plaque redness, scaling and thickness are each assigned a number from 0 to 4 with 4 being worst. The extent of involvement of each region of the body is scored from 0 to 6. Adding up the scores give a range of 0 to 72.

Trial Locations

Locations (59): Horizon Research Group, Inc
🇺🇸
Mobile, Alabama, United States
Burke Pharmaceutical Research
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Hot Springs, Arkansas, United States
Advanced Clinical Research Institute
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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.
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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
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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
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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
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Arlington Hts, Illinois, United States
Glazer Dermatology
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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
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Fridley, Minnesota, United States
Karl G. Heine, M. D. Dermatology
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Henderson, Nevada, United States
Psoriasis Treatment Center of Central NJ
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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