Psoriasis Vulgaris Clinical Trial
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)
Verified date | March 2015 |
Source | LEO Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 1152 |
Est. completion date | March 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Academic Dermatology Associates | Albuquerque | New Mexico |
United States | Atlanta Dermatology, Vein & Research Center | Alpharetta | Georgia |
United States | Advanced Clinical Research Institute | Anaheim | California |
United States | David Fivenson, MD Dermatology, PLC | Ann Arbor | Michigan |
United States | Altman Dermatology Associates | Arlington Hts | Illinois |
United States | Peachtree Dermatology Associates | Atlanta | Georgia |
United States | Great Lakes Research Group, Inc | Bay City | Michigan |
United States | Visions Clinical Research | Boynton Beach | Florida |
United States | Glazer Dermatology | Buffalo Grove | Illinois |
United States | Triangle Medical Research Associates, LLC | Cary | North Carolina |
United States | Michigan Center for Research Corp., | Clinton Twp | Michigan |
United States | J&S Studies, Inc. | College Station | Texas |
United States | Dermatology Associates and Research | Coral Gables | Florida |
United States | Division of Dermatology, Baylor Research Institute | Dallas | Texas |
United States | Colorado Medical Research Center, Inc. | Denver | Colorado |
United States | Horizons Clinical Research Center, LLC | Denver | Colorado |
United States | Henry Ford Health System | Detroit | Michigan |
United States | Psoriasis Treatment Center of Central NJ | East Windsor | New Jersey |
United States | Anderson & Collins Clinical Research, Inc. | Edison | New Jersey |
United States | Deaconess Clinic, Inc. | Evansville | Indiana |
United States | Hudson Dermatology | Evansville | Indiana |
United States | Hamzavi Dermatology | Fort Gratiot | Michigan |
United States | Minnesota Clinical Study Center | Fridley | Minnesota |
United States | Karl G. Heine, M. D. Dermatology | Henderson | Nevada |
United States | Burke Pharmaceutical Research | Hot Springs | Arkansas |
United States | Centre for Clinical Studies | Houston | Texas |
United States | Dawes Fretzin Clinical Research Group | Indianapolis | Indiana |
United States | North Florida Dermatology Associates, PA | Jacksonville | Florida |
United States | King-Maceyko Dermatology Associates | Johnstown | Pennsylvania |
United States | DBA Torrance Clinical Research | Lomita | California |
United States | Dermatology Specialists | Louisville | Kentucky |
United States | Dermatologic Surgery Specialists, PC | Macon | Georgia |
United States | International Dermatology Research, Inc. | Miami | Florida |
United States | Horizon Research Group, Inc | Mobile | Alabama |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Dermatology Specialists, Inc. | Oceanside | California |
United States | Ameriderm Research | Ormond Beach | Florida |
United States | Owensboro Dermatology Associates | Owensboro | Kentucky |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Indiana Clinical Trials Center | Plainfield | Indiana |
United States | Oregon Dermatology and Research Center | Portland | Oregon |
United States | Lawrence J. Green, MD, LLC | Rockville | Maryland |
United States | Dermatology Research Center, Inc. | Salt Lake City | Utah |
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 | 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 | Gwinnett Clinical Research Center, Inc | Snellville | Georgia |
United States | Haber Dermatology and Cosmetic Surgery | South Euclid | Ohio |
United States | Premier Clinical Research | Spokane | Washington |
United States | Derm Research Center of New York | Stony Brook | New York |
United States | Somerset Skin Centre | Troy | Michigan |
United States | The Dermatology Group, PC | Verona | New Jersey |
United States | Grekin Skin Institute | Warren | Michigan |
United States | Palm Beach Research Center | West Palm Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
LEO Pharma |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | Mean Percentage Change in PASI From Baseline to Week 4 | 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. | Baseline and 4 weeks | No |
Secondary | Mean Percentage Change in PASI From Baseline to Week 8 | 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. | Baseline and 8 weeks | No |
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