NCT00932074

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2009

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

11 months

First QC Date

June 30, 2009

Last Update Submit

April 4, 2012

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (1)

  • Investigator's Global Severity Score(IGSS)

    4 weeks

Secondary Outcomes (4)

  • 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

Study Arms (3)

3% KP-413 Ointment

EXPERIMENTAL
Drug: KP-413 Ointment

1% KP-413 Ointment

EXPERIMENTAL
Drug: KP-413 Ointment

Placebo

PLACEBO COMPARATOR
Drug: KP-413 Ointment

Interventions

KP-413 OintmentDRUG

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.

1% KP-413 Ointment3% KP-413 OintmentPlacebo

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Michigan Center for Research Corp

Clinton Twp., Michigan, 48038, United States

Location

Oregon Medical Research Center, PC

Portland, Oregon, 97223, United States

Location

DermResearch, Inc.

Austin, Texas, 78759, United States

Location

J & S Studies, Inc.

College Station, Texas, 77845, United States

Location

Dermatology Treatment & Research Center, PA

Dallas, Texas, 75230, United States

Location

The Education & Research Foundation, Inc

Lynchburg, Virginia, 24501-1604, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Barry Calvarese, MS

    Dow Pharmaceutical Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2009

First Posted

July 2, 2009

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

US(6)