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Efficacy Study Comparing Topical M518101 and Vitamin D3 in Adult Psoriasis Patients

NCT01989429 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 788

Last updated 2015-12-31

No results posted yet for this study

Summary

M5181 - a novel vitamin D3 analogue - is currently under development for the treatment of plaque psoriasis and is being developed as a topical ointment formulation (M518101)

Clinical and non-clinical studies indicate that M5181 is an effective treatment for plaque psoriasis.

Based on the results of previous phase II trials the phase III trial has been designed to evaluate efficacy and safety of an 8-week treatment period with 50 μg/g M518101 in a larger population of patients with stable plaque psoriasis.

Conditions

Interventions

DRUG

M518101

8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse

Sponsors & Collaborators

  • Maruho Co., Ltd.

    collaborator INDUSTRY

  • Maruho Europe Limited

    lead INDUSTRY

Principal Investigators

  • D Thaci, Prof.Dr · University of Lubeck, Dermatology Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Austria
  • Bulgaria
  • Germany
  • Hungary
  • Lithuania
  • Poland

Study Locations

More Related Trials

Entities

Diseases

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 NCT01989429 on ClinicalTrials.gov