A Study of E6005 in Japanese Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: E6005
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: E6005<br>* Four Steps of Ointment Application: Step 1: 0.01% of E6005; Step 2: 0.03% of E6005; Step 3: 0.1% of E6005; Step 4: 0.2% of E6005.<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* Matching placebo for each step<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter Cmax will be calculated |  | Until Day 13 | 
| Pharmacokinetic parameter tmax will be calculated |  | Until Day 13 | 
| Pharmacokinetic parameter AUC(0-t) will be calculated |  | Until Day 13 | 
| Pharmacokinetic parameter t1/2 will be calculated |  | Until Day 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dermatitis, Atopic