A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Atopic Dermatitis
In brief
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).
Key facts
- Study ID
- NCT00932074
- Run by
- Kaken Pharmaceutical
- People needed
- 58
- Starts
- 2009-07-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2012-04-06
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Michigan Center for Research Corp — Clinton Twp., Michigan, United States
- Oregon Medical Research Center, PC — Portland, Oregon, United States
- DermResearch, Inc. — Austin, Texas, United States
- J & S Studies, Inc. — College Station, Texas, United States
- Dermatology Treatment & Research Center, PA — Dallas, Texas, United States
- The Education & Research Foundation, Inc — Lynchburg, Virginia, United States
Full record on ClinicalTrials.gov
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