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

Maruho Co., Ltd.1 site in 1 country80 target enrollmentMarch 8, 2017

ConditionsAtopic Dermatitis

InterventionsOmiganan Placebo

DrugsOmiganan Placebo

Overview

Phase: Phase 2
Intervention: Omiganan
Conditions: Atopic Dermatitis
Sponsor: Maruho Co., Ltd.
Enrollment: 80
Locations: 1
Primary Endpoint: Pharmacodynamics (Biomarkers)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

March 8, 2017

End Date

December 20, 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Maruho Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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.