Clinical trial NCT01179880: A Study of E6005 in Japanese Patients With Atopic Dermatitis
Official title: A Phase 1/2 Study of E6005 in Japanese Patients With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Keywords: Dermatitis
Atopic
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 40
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pharmacokinetic parameter Cmax will be calculated
timeFrame: Until Day 13
measure: Pharmacokinetic parameter tmax will be calculated
timeFrame: Until Day 13
measure: Pharmacokinetic parameter AUC(0-t) will be calculated
timeFrame: Until Day 13
measure: Pharmacokinetic parameter t1/2 will be calculated
timeFrame: Until Day 13
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
Study officials:
References:
citation: 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.