A Study to Determine the Safety, Tolerability and Efficacy of KP-413 in Subjects With Atopic Dermatitis(AD)

Phase 1

Completed

• Conditions: Atopic Dermatitis
• Interventions: Drug: KP-413 Ointment

• Registration Number: NCT00932074
• Lead Sponsor: Kaken Pharmaceutical

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-30
• Study First Submitted QC: 2009-06-30
• Study Start: 2009-07
• Study First Posted: 2009-07-02
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-04
• Last Update Posted: 2012-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3% KP-413 Ointment	KP-413 Ointment	-
1% KP-413 Ointment	KP-413 Ointment	-
Placebo	KP-413 Ointment	-

Primary Outcome Measures

Name	Time	Method
Investigator's Global Severity Score(IGSS)	4 weeks

Secondary Outcome Measures

Name	Time	Method
Plasma levels of KP-413	6 weeks
Signs and Symptoms of AD	4 weeks
Subject's Numerical Rating Scale(NRS) of Pruritus Score	4 weeks
Percent of AD-affected body surface area (BSA)	4 weeks

Trial Locations

Locations (6)

Oregon Medical Research Center, PC; 🇺🇸 Portland, Oregon, United States

Michigan Center for Research Corp; 🇺🇸 Clinton Twp., Michigan, United States

J & S Studies, Inc.; 🇺🇸 College Station, Texas, United States

DermResearch, Inc.; 🇺🇸 Austin, Texas, United States

Dermatology Treatment & Research Center, PA; 🇺🇸 Dallas, Texas, United States

The Education & Research Foundation, Inc; 🇺🇸 Lynchburg, Virginia, United States