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Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

NCT ID: NCT03091426

Last Updated: 2017-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-08

Study Completion Date

2017-12-20

Brief Summary

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This study has a randomized, double-blind, placebo-controlled design to assess the efficacy, pharmacodynamics and safety/tolerability of omiganan in patients with mild to moderate atopic dermatitis when applied BID to all atopic dermatitis lesions.

Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Omiganan 1%

Group Type EXPERIMENTAL

Omiganan

Intervention Type DRUG

Omiganan 1%

Omiganan 1.75%

Group Type EXPERIMENTAL

Omiganan

Intervention Type DRUG

Omiganan 1.75%

Omiganan 2.5%

Group Type EXPERIMENTAL

Omiganan

Intervention Type DRUG

Omiganan 2.5%

Vehicle

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Vehicle

Interventions

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Omiganan

Omiganan 1%

Intervention Type DRUG

Omiganan

Omiganan 1.75%

Intervention Type DRUG

Omiganan

Omiganan 2.5%

Intervention Type DRUG

Placebo

Vehicle

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female subjects with mild to moderate AD (IGA 2 or 3) 18 to 65 years of age,inclusive. The health status is verified by absence of evidence of any clinical significant active or uncontrolled chronic disease other than AD following a detailed medical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, virology and urinalysis;
* Confirmed AD diagnosis;
* Symptoms present for at least 1 year;
* EASI between 7.1 - 50.0, inclusive at screening;
* 2-20% body surface area (BSA) affected at screening;
* Body mass index (BMI) between 18 and 35 kg/m2, inclusive, and with a minimum weight of 50 kg;
* Able to participate and willing to give written informed consent and to comply with the study restrictions;
* Subjects and their partners of childbearing potential must use effective contraception, for the duration of the study and for 3 months after the last dose.

Exclusion Criteria

* Any current and / or recurrent clinical significant skin condition other than AD;
* Pregnant, a positive pregnancy test, intending to become pregnant, or breastfeeding;
* Ongoing use of prohibited atopic dermatitis treatments. Requires washout period prior to baseline (first dose of the study drug);
* Use of topical medication (prescription or over-the-counter \[OTC\]) within 14 days of study drug administration, or less than 5 half-lives (whichever is longer) in local treatment area;
* Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks of enrollment;
* Known hypersensitivity to the compound or excipients of the compound or known hypersensitivity to one or more different emollients;
* Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year;
* Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maruho Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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J. (Koos) Burggraaf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Human Drug Research

Locations

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LUMC/Centre for Human Drug Research

Leiden, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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2016-003849-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLS001-CO-PR-014

Identifier Type: -

Identifier Source: org_study_id