Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

• Status: Completed
• Trial end date: 2015-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cutanea Life Sciences, Inc.; Maruho Co., Ltd.

Criteria

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.