A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01461941

Enrollment

Registered

2011-10-28

Start date

2011-12-31

Completion date

2013-01-31

Last updated

2025-06-03

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

Conditions

Atopic Dermatitis

Keywords

Dermatitis, Atopic

Brief summary

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.

Interventions

DRUGE6005

0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.

DRUGE6005 ointment (vehicle)

0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Changes of eczema area and severity from baseline	From baseline through 12 weeks
Changes of pruritus score from baseline	From baseline through 12 weeks

Countries

Japan

Outcome results

None listed

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