Status:
COMPLETED
A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)
Lead Sponsor:
Kaken Pharmaceutical
Collaborating Sponsors:
Dow Pharmaceutical Sciences
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety, tolerability and efficacy of KP-413 topical ointment compared with vehicle ointment in treating adult subjects with atopic dermatitis (AD).
Eligibility Criteria
Inclusion
- Has a clear diagnosis of AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5-30% of the subject's total BSA as determined using the rule of nines
- Has a Baseline IGSS of 3(moderate) or 4(severe) in the selected treatment area on the torso/limbs, and a Baseline IGSS of 2(mild), 3(moderate) or 4(severe) in the selected treatment area on the head/neck.
- Female of childbearing potential has a negative pregnancy test and will be using an effective method of contraception during the study.
Exclusion
- Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.
- Has a Baseline oozing/crusting score of 3(moderate) or greater at the selected treatment area on the head/neck or torso/limbs.
- Presence of a concurrent skin condition that could interfere with assessment of treatment.
- Treatment with any investigational drug or device within 30 days or 5 half lives(whichever is longer) prior to the Baseline visit, or concurrent participation in another clinical trial with an investigational drug or device.
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00932074
Start Date
July 1 2009
End Date
June 1 2010
Last Update
April 6 2012
Active Locations (6)
Enter a location and click search to find clinical trials sorted by distance.
1
Michigan Center for Research Corp
Clinton Twp., Michigan, United States, 48038
2
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
3
DermResearch, Inc.
Austin, Texas, United States, 78759
4
J & S Studies, Inc.
College Station, Texas, United States, 77845