Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Maruho

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Vehicle; Drug: CLS001

Study type: Interventional

Funder types: Industry

Identifiers

NCT02456480

2014-003689-26 (EudraCT Number)

CLS001-CO-PR-008

Details and patient eligibility

About

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

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 3 patient groups, including a placebo group

CLS001 topical gel, 2.5%

Experimental group

Treatment:

Drug: CLS001

CLS001 topical gel 1%

Experimental group

Treatment:

Drug: CLS001

Vehicle gel

Placebo Comparator group

Treatment:

Drug: Vehicle