Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

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).

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Detailed Description

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Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CLS001 topical gel, 2.5%

Group Type EXPERIMENTAL

CLS001

Intervention Type DRUG

topical gel

CLS001 topical gel 1%

Group Type EXPERIMENTAL

CLS001

Intervention Type DRUG

topical gel

Vehicle gel

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

topical gel

Interventions

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CLS001

topical gel

Intervention Type DRUG

Vehicle

topical gel

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No