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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KP-413 Ointment
Sponsored by
Kaken Pharmaceutical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic Dermatitis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Michigan Center for Research Corp
  • Oregon Medical Research Center, PC
  • DermResearch, Inc.
  • J & S Studies, Inc.
  • Dermatology Treatment & Research Center, PA
  • The Education & Research Foundation, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

3% KP-413 Ointment

1% KP-413 Ointment

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Investigator's Global Severity Score(IGSS)

Secondary Outcome Measures

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

Full Information

First Posted
June 30, 2009
Last Updated
April 4, 2012
Sponsor
Kaken Pharmaceutical
Collaborators
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00932074
Brief Title
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

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaken Pharmaceutical
Collaborators
Dow Pharmaceutical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
3% KP-413 Ointment
Arm Type
Experimental
Arm Title
1% KP-413 Ointment
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
KP-413 Ointment
Intervention Description
Study drug ointment to be applied topically to the selected treatment areas on the head/neck and torso/limbs twice a day for 4 weeks.
Primary Outcome Measure Information:
Title
Investigator's Global Severity Score(IGSS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Plasma levels of KP-413
Time Frame
6 weeks
Title
Signs and Symptoms of AD
Time Frame
4 weeks
Title
Subject's Numerical Rating Scale(NRS) of Pruritus Score
Time Frame
4 weeks
Title
Percent of AD-affected body surface area (BSA)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barry Calvarese, MS
Organizational Affiliation
Dow Pharmaceutical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Michigan Center for Research Corp
City
Clinton Twp.
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Oregon Medical Research Center, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97223
Country
United States
Facility Name
DermResearch, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies, Inc.
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Dermatology Treatment & Research Center, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
The Education & Research Foundation, Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501-1604
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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