Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

July 25, 2016 updated by: Maruho Co., Ltd.

A Randomized, Double-blind, Placebo Controlled Study to Assess the Pharmacodynamics, Safety/Tolerability and Efficacy of Omiganan in Patients With Mild to Moderate Atopic Dermatitis

To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

37

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Zernikedreef 8, Netherlands
        • Centre For Human Drug Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive.
  2. AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year
  3. Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

  1. Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD.
  2. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients.
  3. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Vehicle gel
Drug: Vehicle
topical gel
Experimental: CLS001 topical gel, 2.5%
Drug: CLS001
topical gel
Experimental: CLS001 topical gel 1%
Drug: CLS001
topical gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamic (Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion)
Time Frame: 42 Days
Local punch biopsy of a target lesion pre-dose and post treatment for the change in biomarkers including IL, filaggrin, TLR, IgE, IFN, and microbiome of the skin lesion
42 Days
Clinical assessment (Change in patient symptoms over time using pruritis VAS)
Time Frame: 42 Days
Change in patient symptoms over time using pruritis VAS
42 Days
Clinical Assessment (Change in lesion size over time)
Time Frame: 42 Days
Change in lesion size over time
42 Days
Clinical assessment (Change in patient SCORAD scale score over time)
Time Frame: 42 Days
Change in patient SCORAD scale score over time
42 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety Assessment (Adverse events)
Time Frame: 42 days
Adverse events will be collected throughout the study
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maruho Co., Ltd.

Investigators

  • Principal Investigator: J. (Koos) Burggraaf, MD, PhD, Centre For Human Drug Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

May 1, 2015

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 25, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLS001-CO-PR-008
  • 2014-003689-26 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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