Pharmacodynamics of Omiganan BID in Patients With Atopic Dermatitis

Maruho

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Omiganan; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03091426

2016-003849-28 (EudraCT Number)

CLS001-CO-PR-014

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 4 patient groups, including a placebo group

Omiganan 1%

Experimental group

Treatment:

Drug: Omiganan

Drug: Omiganan

Drug: Omiganan

Omiganan 1.75%

Experimental group

Treatment:

Drug: Omiganan

Drug: Omiganan

Drug: Omiganan

Omiganan 2.5%

Experimental group

Treatment:

Drug: Omiganan

Drug: Omiganan

Drug: Omiganan

Vehicle

Placebo Comparator group

Treatment:

Drug: Placebo