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LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris | Clinical Trials | Clareo Health

COMPLETEDPHASE2

LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

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.

NCT01536886•LEO Pharma

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+10 more criteria

Locations (39)

Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Dermatology Research Associates

Los Angeles, California, United States

Dermatology Specialists, Inc.

Oceanside, California, 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

About Skin Dermatology and DermSurgery, PC

Denver, Colorado, United States

Colorado Medical Research Center, Inc

Denver, Colorado, United States

Horizons Clinical Research Center

Denver, Colorado, United States

Dermatology Associates and Research

Coral Gables, Florida, United States

Key Dates

Start Date

May 1, 2012

Primary Completion Date

September 1, 2012

Completion Date

November 1, 2012

Last Updated

March 7, 2025

Enrollment

376

ACTUAL participants

Conditions

Psoriasis Vulgaris

Interventions

LEO 90100

DRUG

Betamethasone plus calcipotriol

DRUG

Ointment vehicle

DRUG

LEO 90100 vehicle

DRUG

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

NCT04080635

Psoriasis Vulgaris

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COMPLETEDPHASE4

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

NCT04340076

PsoriasisPsoriasis Vulgaris

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WITHDRAWNNA

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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LEO 90100 Compared With Calcipotriol Plus Betamethasone Dipropionate Ointment, LEO 90100 Vehicle and Ointment Vehicle in Subjects With Psoriasis Vulgaris

Inclusion Criteria

Exclusion Criteria

Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis

Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP

A Pilot Study to Explore the Role of Gut Flora in Psoriasis

The Mediterranean Diet and Time-Restricted Eating Dietary Interventions for Psoriasis Study