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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01188928
Other study ID # LEO 80185-G23
Secondary ID
Status Completed
Phase Phase 3
First received August 25, 2010
Last updated March 25, 2015
Start date September 2010
Est. completion date March 2011

Study information

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

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Calcipotriol plus betamethasone
Topical suspension once daily for up to 8 weeks.
Betamethasone-17,21-dipropionate
Topical suspension once daily for up to 8 weeks.
Calcipotriene
Topical suspension once daily for up to 8 weeks.
Topical suspension vehicle
Topical suspension once daily for up to 8 weeks.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

Outcome

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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