A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Organon

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: E6005; Drug: E6005 ointment (vehicle)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01461941

E6005-J081-201

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after topical application of E6005 is also assessed.

Enrollment: 78 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Adults of both genders aged 20 to 64 years at the time when the written informed consent is obtained.
• Outpatients diagnosed with atopic dermatitis.

Exclusion Criteria

• Patients with a present illness of Kaposi's varicelliform eruption, scabies, molluscum contagiosum, impetigo contagious, psoriasis, connective tissue disorder, collagen disorder or Netherton's syndrome, etc., which could have an effect on the pathological evaluation of the atopic dermatitis.
• Patients with active infection that requires oral or intravenous administration of antibiotics, antifungal or antivirus agent/s at baseline.
• Patients with advanced disease or abnormal laboratory tests that would possibly affect the safety of the subject or the implementation of this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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78 participants in 2 patient groups, including a placebo group

Drug: 0.2% E6005 ointment

Experimental group

Treatment:

Drug: E6005

Drug: 0.0% E6005 ointment (vehicle)

Placebo Comparator group

Treatment:

Drug: E6005 ointment (vehicle)