LEO 90100 in the Treatment of Psoriasis Vulgaris

NCT01536938 | Completed Phase 2 Results

• 1 other identifier: LEO 90100-7
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 33

Brief Summary

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

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Calcipotriol

ACTIVE COMPARATOR

Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks

Drug: Calcipotriol

Betamethasone

ACTIVE COMPARATOR

Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks

Drug: Betamethasone

LEO 90100

EXPERIMENTAL

LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks

Drug: LEO 90100

Interventions

LEO 90100 DRUG

Also known as: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)

LEO 90100

Calcipotriol DRUG

Calcipotriol

Betamethasone DRUG

Betamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LEO Pharma: lead

Study Sites (33)

Burke Pharmaceutical Research

Hot Springs, Arkansas, 71913, United States

Location

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Dermatology Specialists, Inc.

Oceanside, California, 92056, United States

Location

Skin Surgery Medical Group, Inc

San Diego, California, 92117, United States

Location

University Clinical Trials, Inc.

San Diego, California, 92123, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Colorado Medical Research Center, Inc

Denver, Colorado, 80210, United States

Location

Horizons Clinical Research Center

Denver, Colorado, 80220, United States

Location

Dermatology Associates and Research

Coral Gables, Florida, 33134, United States

Location

North Florida Dermatology Associates, PA

Jacksonville, Florida, 32204, United States

Location

International Dermatology Research, Inc.

Miami, Florida, 33144, United States

Location

Altman Dermatology Associates

Arlington Heights, Illinois, 60005, United States

Location

Glazer Dermatology

Buffalo Grove, Illinois, 60089, United States

Location

Clinical Research Advantage, Inc./Hudson Dermatology, LLC

Evansville, Indiana, 47714, United States

Location

Dawes Fretzin Clinical Research Group

Indianapolis, Indiana, 46256, United States

Location

The Indiana Clinical Trials Center

Plainfield, Indiana, 46168, United States

Location

Owensboro Dermatology Associates

Owensboro, Kentucky, 42303, United States

Location

David Fivenson, MD, PLC

Ann Arbor, Michigan, 48103, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Derm Center

Troy, Michigan, 48084, United States

Location

Grekin Skin Institute

Warren, Michigan, 48008, United States

Location

Minnesota Clinical Study Center

Fridley, Minnesota, 55432, United States

Location

Psoriasis Treatment Center of Central NJ

East Windsor, New Jersey, 08520, United States

Location

The Dermatology Group, PC

Verona, New Jersey, 07044, United States

Location

Derm Research Center of New York

Stony Brook, New York, 11790, United States

Location

Philadelphia Institute of Dermatology

Fort Washington, Pennsylvania, 19034, United States

Location

Menter Dermatology Research Institute

Dallas, Texas, 75246, United States

Location

Center for Clinical Studies

Houston, Texas, 77065, United States

Location

Clinical Trials of Texas, Inc

San Antonio, Texas, 78229, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78229, United States

Location

Virginia Clinical Research, Inc.

Norfolk, Virginia, 23507, United States

Location

Premier Clinical Research

Spokane, Washington, 99204, United States

Location

Related Publications (2)

• Lebwohl M, Tyring S, Bukhalo M, Alonso-Llamazares J, Olesen M, Lowson D, Yamauchi P. Fixed Combination Aerosol Foam Calcipotriene 0.005% (Cal) Plus Betamethasone Dipropionate 0.064% (BD) is More Efficacious than Cal or BD Aerosol Foam Alone for Psoriasis Vulgaris: A Randomized, Double-blind, Multicenter, Three-arm, Phase 2 Study. J Clin Aesthet Dermatol. 2016 Feb;9(2):34-41. Epub 2016 Feb 1.

  PMID: 27313822 BACKGROUND

• Veverka KA, Hansen JB, Yaloumis M, Kircik L, Stein Gold L. Calcipotriene Plus Betamethasone Dipropionate Foam for Mild Psoriasis: Pooled Results from Three Randomized Trials. J Drugs Dermatol. 2021 Aug 1;20(8):822-828. doi: 10.36849/JDD.5743.

  PMID: 34397196 DERIVED

Related Links

• Clinical Trials at LEO Pharma

MeSH Terms

Interventions

calcipotriene; Betamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Clinical Trial Disclosure Manager
• Organization: LEO Pharma A/S

ctr.disclosure@leo-pharma.com

+45 44945888

Study Officials

• Mark Lebwohl, M.D.

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2012
• First Posted: February 22, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 7, 2025
• Results First Posted: December 9, 2015

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (33)