A Study of E6005 in Japanese Patients With Atopic Dermatitis

Organon

Status and phase

Completed

Phase 2

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: E6005

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01179880

E6005-J081-101

Details and patient eligibility

About

The safety and pharmacokinetics of topical application with E6005 ointment compared to vehicle will be evaluated in Japanese male patients with atopic dermatitis. Additionally, the efficacy of topical application with E6005 ointment will be explored in Japanese male patients with atopic dermatitis.

Enrollment

40 patients

Sex

Male

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria;

Japanese adult male patients with a confirmed diagnosis of atopic dermatitis according to "Guidelines for Management of Atopic Dermatitis" by the Japanese Dermatological Association.
Patients with evaluable typical eczema on the back (posterior trunk).
Patients whose age is equal to or more than 20 and less than 65 at the time of treatment and who can provide written informed consent.

Exclusion criteria;

Patients complicated with eye symptoms (e.g., cataract, retinal detachment), Kaposi varicelliform eruption, and molluscum contagiosum or impetigo contagiosa.
Patients who had or have a severe allergy such as anaphylactic shock, anaphylactic reaction and anaphylactoid reaction or allergy/hypersensitivity to E6005 or any of their excipients.
Patients who received any concomitant ethical drugs or any phototherapies within 14 days prior to Baseline. Subjects are allowed to use external steroids and tacrolimus ointment 8 or more days before Baseline and bland emollients free of medicinal properties (e.g., white petrolatum) throughout the study period.
Patients with any infection that required hospitalization or intravenous/oral treatment with antibiotic/antiviral/antifungal drug(s) within 28 days prior to Baseline.
Patients who had or have any malignancy, lymphoma, leukemia, or lymphoproliferative disorders, which dose not include skin cancers (e.g., squamous cell carcinoma or basal cell cancer) that were completely removed and have not metastasized for 5 years.