NCT01461941

A Phase 2 Study of E6005 in Patients With Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Organon and Co · Industry
• Sex: All
• Age: 20 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety profiles of E6005 ointment in patients with atopic dermatitis compared to vehicle. The pharmacokinetic profile after topical application of E6005 is also assessed.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	E6005	0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
DRUG	E6005 ointment (vehicle)	0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-11-01
• Completion: 2013-01-01
• First posted: 2011-10-28
• Last updated: 2025-06-03

Locations

10 sites across 1 country: Japan