A Study of E6005 in Japanese Patients With Atopic Dermatitis

NCT01179880 | Completed Phase 1

• 1 other identifier: E6005-J081-101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atopic Dermatitis

Keywords

Dermatitis; Atopic

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: E6005

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

E6005 DRUG

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.

1

Placebo DRUG

Matching placebo for each step

2

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Organon and Co: lead

Study Sites (1)

Unknown Facility

Fukuoka, Japan

Location

Related Publications (1)

• Ohba F, Nomoto M, Hojo S, Akama H. Safety, tolerability and pharmacokinetics of a novel phosphodiesterase inhibitor, E6005 ointment, in healthy volunteers and in patients with atopic dermatitis. J Dermatolog Treat. 2016;27(3):241-6. doi: 10.3109/09546634.2015.1093587. Epub 2015 Nov 18.

  PMID: 26581111 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Dermatitis

Interventions

methyl 4-(((3-(6,7-dimethoxy-2-(methylamino)quinazolin-4-yl)phenyl)amino)carbonyl)benzoate

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 11, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: June 4, 2025

Record last verified: 2018-02

Locations

JP (1)