LEO 90100 in the Treatment of Psoriasis Vulgaris

Psoriasis Vulgaris Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01536938
• Other study ID #: LEO 90100-7
• Status: Completed
• Phase: Phase 2
• First received: February 16, 2012
• Last updated: January 26, 2016
• Start date: May 2012
• Est. completion date: November 2012

Study information

• Verified date: January 2016
• 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 investigate whether LEO 90100, calcipotriol and betamethasone are effective in the treatment of psoriasis vulgaris.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• 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 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.

Study Design

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

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

Drug:
• LEO 90100

• Calcipotriol

• Betamethasone

Locations

Country	Name	City	State
United States	David Fivenson, MD, PLC	Ann Arbor	Michigan
United States	Altman Dermatology Associates	Arlington Heights	Illinois
United States	Great Lakes Research Group, Inc.	Bay City	Michigan
United States	Glazer Dermatology	Buffalo Grove	Illinois
United States	Dermatology Associates and Research	Coral Gables	Florida
United States	Menter Dermatology Research Institute	Dallas	Texas
United States	Colorado Medical Research Center, Inc	Denver	Colorado
United States	Horizons Clinical Research Center	Denver	Colorado
United States	Psoriasis Treatment Center of Central NJ	East Windsor	New Jersey
United States	Clinical Research Advantage, Inc./Hudson Dermatology, LLC	Evansville	Indiana
United States	Philadelphia Institute of Dermatology	Fort Washington	Pennsylvania
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
United States	Center 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	Dermatology Research Associates	Los Angeles	California
United States	International Dermatology Research, Inc.	Miami	Florida
United States	Virginia Clinical Research, Inc.	Norfolk	Virginia
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Owensboro Dermatology Associates	Owensboro	Kentucky
United States	The Indiana Clinical Trials Center	Plainfield	Indiana
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	San Antonio	Texas
United States	Skin Surgery Medical Group, Inc	San Diego	California
United States	University Clinical Trials, Inc.	San Diego	California
United States	Clinical Science Institute	Santa Monica	California
United States	Premier Clinical Research	Spokane	Washington
United States	Derm Research Center of New York	Stony Brook	New York
United States	Derm Center	Troy	Michigan
United States	The Dermatology Group, PC	Verona	New Jersey
United States	Grekin Skin Institute	Warren	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

United States, 

References & Publications (2)

Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. A novel aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal and BD foam alone in treating psoriasis vulgaris: a randomized, double-blind, multicenter, three-arm, Phase II study. J Am Acad Dermatol. 2015:72 Suppl 1;AB222 (P1670).

Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. An innovative aerosol foam formulation of calcipotriene 0.005% (Cal) plus betamethasone dipropionate 0.064% (BD) is more efficacious than Cal or BD aerosol foam alone in

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessment of disease severity (Plaque thickening, Scaling and Erythema) using a 5-point scale (Clear, Almost clear, Mild, Moderate, Severe), based on the condition of the disease at the time of evaluation.	4 weeks	No