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LEO 90100 Twice Weekly Maintenance Regimen for Psoriasis Vulgaris

NCT02899962 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 722

Last updated 2020-08-20

Study results available
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Summary

A phase 3 trial comparing the efficacy and safety of LEO 90100 aerosol foam with the aerosol foam vehicle used twice weekly as long-term maintenance therapy in subjects with psoriasis vulgaris.

A 12-month, international, multi-centre, randomised, vehicle controlled, double-blind, 2-arm, parallel group trial.

Conditions

  • Psoriasis Vulgaris

Interventions

DRUG

LEO 90100 aerosol foam

LEO 90100 aerosol foam twice weekly

DRUG

LEO 90100 aerosol foam vehicle

LEO 90100 aerosol foam vehicle twice weekly

Sponsors & Collaborators

  • LEO Pharma

    lead INDUSTRY

Principal Investigators

  • Mark Lebwohl, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2019-06-26
Completion
2019-06-26
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02899962 on ClinicalTrials.gov