Clinical trial NCT01536886: LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris
Official title: A Phase 2 Study Comparing Treatment With LEO 90100 With Calcipotriol Plus Betamethasone Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2012-02-22
Enrollment: 376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether LEO 90100 and calcipotriol plus betamethasone are effective in the treatment of psoriasis vulgaris.


Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent obtained prior to any trial related activities (including washout period).
* Age 18 years or above
* Either sex
* Any race or ethnicity
* All skin types
* 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).
* 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 8 weeks prior to randomisation
  * ustekinumab - within 16 weeks prior to randomisation
  * other products - 4 weeks/5 half-lives (whichever is longer)
* Systemic treatment with all other therapies with a possible effect on psoriasis vulgaris (e.g., corticosteroids, retinoids, methotrexate, ciclosporin and other immunosuppressants) within 4 weeks prior to randomisation.
* Subjects who have received treatment with any nonmarketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
* PUVA therapy within 4 weeks prior to randomisation.
* UVB therapy within 2 weeks prior to randomisation.
* Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps, etc.) during the study.
* Planned initiation of, or changes to, concomitant medication that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, 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, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, icthyosis, ulcers and wounds.
* Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis vulgaris.
* 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.
* Previously randomised in this study.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

Primary outcomes:
measure: Subjects With 'Controlled Disease' ('Clear'/'Almost Clear' for Subjects w. at Least Moderate Disease at Baseline, 'Clear' for Subjects With Mild Disease at Baseline) According to the Investigator's Global Assessment (IGA) on the Trunk and Limbs at Week 4.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute
state: California
city: Denver
country: United States
facility: About Skin Dermatology and DermSurgery, PC
state: Colorado
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc
state: Colorado
city: Denver
country: United States
facility: Horizons Clinical Research Center
state: Colorado
city: Coral Gables
country: United States
facility: Dermatology Associates and Research
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates, PA
state: Florida
city: Miami
country: United States
facility: International Dermatology Research, Inc.
state: Florida
city: Ormond Beach
country: United States
facility: Ameriderm Research
state: Florida
city: Snellville
country: United States
facility: Gwinnett Clinical Research Ctr, Inc
state: Georgia
city: Arlington Heights
country: United States
facility: Altman Dermatology Associates
state: Illinois
city: Buffalo Grove
country: United States
facility: Glazer Dermatology
state: Illinois
city: Evansville
country: United States
facility: Clinical Research Advantage, Inc./Hudson Dermatology, LLC
state: Indiana
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center
state: Indiana
city: Owensboro
country: United States
facility: Owensboro Dermatology Associates
state: Kentucky
city: Ann Arbor
country: United States
facility: David Fivenson, MD, PLC
state: Michigan
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Troy
country: United States
facility: Derm Center
state: Michigan
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: East Windsor
country: United States
facility: Psoriasis Treatment Center of Central NJ
state: New Jersey
city: Verona
country: United States
facility: The Dermatology Group, PC
state: New Jersey
city: Albuquerque
country: United States
facility: Academic Dermatology Associates
state: New Mexico
city: Stony Brook
country: United States
facility: Derm Research Center of New York
state: New York
city: Fort Washington
country: United States
facility: Philadelphia Institute of Dermatology
state: Pennsylvania
city: Dallas
country: United States
facility: Menter Dermatology Research Institute
state: Texas
city: Houston
country: United States
facility: Suzanne Bruce and Associates, P.A.,The Center for Skin Research
state: Texas
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center, Inc.
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
affiliation: University of California, San Francisco School of Medicine
name: John Koo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koo J, Tyring S, Werschler WP, Bruce S, Olesen M, Villumsen J, Bagel J. Superior efficacy of the fixed combination calcipotriene plus betamethasone dipropionate in a novel aerosol foam versus ointment in patients with psoriasis vulgaris. Semin Cutan Med Surg. 2015;34 S1:PA-42.
citation: Iversen L, Kurvits M, Snel-Prento AM, Menter A. Calcipotriol/Betamethasone Dipropionate Cutaneous Foam Treatment for Psoriasis in Patients With BSA 5-15% and PGA >/= 3: Post-Hoc Analysis From Three Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Oct;10(5):1111-1120. doi: 10.1007/s13555-020-00419-2. Epub 2020 Aug 12.