Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

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

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: CLS001
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female subjects with mild to moderate AD 18 to 65 years of age, inclusive. AD diagnosed by physician / medical specialist and that has been (intermittently) present for at least 1 year Able to participate and willing to give written informed consent and to comply with the study restrictions. Exclusion Criteria: Have any current and / or recurrent clinically significant skin condition in the treatment area other than AD. Any confirmed, active significant allergic reactions (urticaria or anaphylaxis) including allergic reactions against any drug, multiple drug allergies or (ingredients of) emollients. Participation in an investigational drug or device study within 3 months prior to screening or more than 4 times a year.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLS001 topical gel, 2.5%<br> | Drug: CLS001<br>* topical gel<br>|
| Experimental: CLS001 topical gel 1%<br> | Drug: CLS001<br>* topical gel<br>|
| Placebo Comparator: Vehicle gel<br> | Drug: Vehicle<br>* topical gel<br>|

What is the study measuring?
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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) | 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) | Change in patient symptoms over time using pruritis VAS | 42 Days | 
| Clinical Assessment (Change in lesion size over time) | Change in lesion size over time | 42 Days | 
| Clinical assessment (Change in patient SCORAD scale score over time) | Change in patient SCORAD scale score over time | 42 Days | 

Secondary Outcome Measures

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