Clinical trial NCT00932074: A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)
Official title: A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment in Subjects With Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Lead sponsor: Kaken Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Dow Pharmaceutical Sciences
First posted: 2009-07-02
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Investigator's Global Severity Score(IGSS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Plasma levels of KP-413
timeFrame: 6 weeks
measure: Signs and Symptoms of AD
timeFrame: 4 weeks
measure: Subject's Numerical Rating Scale(NRS) of Pruritus Score
timeFrame: 4 weeks
measure: Percent of AD-affected body surface area (BSA)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Clinton Twp.
country: United States
facility: Michigan Center for Research Corp
state: Michigan
city: Portland
country: United States
facility: Oregon Medical Research Center, PC
state: Oregon
city: Austin
country: United States
facility: DermResearch, Inc.
state: Texas
city: College Station
country: United States
facility: J & S Studies, Inc.
state: Texas
city: Dallas
country: United States
facility: Dermatology Treatment & Research Center, PA
state: Texas
city: Lynchburg
country: United States
facility: The Education & Research Foundation, Inc
state: Virginia
Study officials:
affiliation: Dow Pharmaceutical Sciences
name: Barry Calvarese, MS
role: STUDY_DIRECTOR
References: