Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Maruho Co., Ltd.37 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

CLS001DRUG

topical gel

VehicleDRUG

topical gel

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centre for Human Drug Research

Zernikedreef 8, Netherlands

Outcomes

Primary Outcomes

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)

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

Clinical assessment (Change in patient symptoms over time using pruritis VAS)

Change in patient symptoms over time using pruritis VAS

Time frame: 42 Days

Clinical Assessment (Change in lesion size over time)

Change in lesion size over time

Time frame: 42 Days

Clinical assessment (Change in patient SCORAD scale score over time)

Change in patient SCORAD scale score over time

Time frame: 42 Days

Secondary Outcomes

Safety Assessment (Adverse events)

Adverse events will be collected throughout the study

Time frame: 42 days

Data from ClinicalTrials.gov

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