Fukuoka, Japan
NCT Number: NCT01179880
A Study of E6005 in Japanese Patients With Atopic Dermatitis
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
20 year–65 year
Sex eligibility
Male
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
E6005
DrugFour 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.
Placebo
DrugMatching placebo for each step
Primary outcomes
-
Pharmacokinetic parameter Cmax will be calculated
Time frame: Until Day 13
-
Pharmacokinetic parameter tmax will be calculated
Time frame: Until Day 13
-
Pharmacokinetic parameter AUC(0-t) will be calculated
Time frame: Until Day 13
-
Pharmacokinetic parameter t1/2 will be calculated
Time frame: Until Day 13
Sponsors and collaborators
Lead sponsor
Organon and Co
Industry
Registry information
Official study title
A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Aug 11, 2010
- Registry last updated
- Jun 4, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic Dermatitis
NCT05990725
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Augsburg, Germany
View Trial DetailsLong-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participant With Moderate-to-Severe Atopic Dermatitis
NCT05916365
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Darmstadt, Hesse, Germany
View Trial DetailsStudy of ATI-2138 in Adult Participants With Moderate to Severe Atopic Dermatitis
NCT06585202
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Birmingham, Alabama, United States
View Trial DetailsLong-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin)
NCT04392154
Atopic Dermatitis, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Anniston, Alabama, United States
View Trial Details