Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456480

Enrollment

Registered

2015-05-28

Start date

2015-05-31

Completion date

2015-11-30

Last updated

2016-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Brief summary

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

Interventions

DRUGCLS001

topical gel

DRUGVehicle

topical gel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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)	42 Days	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
Clinical assessment (Change in patient symptoms over time using pruritis VAS)	42 Days	Change in patient symptoms over time using pruritis VAS
Clinical Assessment (Change in lesion size over time)	42 Days	Change in lesion size over time
Clinical assessment (Change in patient SCORAD scale score over time)	42 Days	Change in patient SCORAD scale score over time

Secondary

Measure	Time frame	Description
Safety Assessment (Adverse events)	42 days	Adverse events will be collected throughout the study

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026