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

This study has been completed.
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Kaken Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00932074
First received: June 30, 2009
Last updated: April 4, 2012
Last verified: April 2012
  Purpose

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).


Condition Intervention Phase
Atopic Dermatitis
Drug: KP-413 Ointment
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment in Subjects With Atopic Dermatitis

Further study details as provided by Kaken Pharmaceutical:

Primary Outcome Measures:
  • Investigator's Global Severity Score(IGSS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma levels of KP-413 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Signs and Symptoms of AD [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Subject's Numerical Rating Scale(NRS) of Pruritus Score [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Percent of AD-affected body surface area (BSA) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 58
Study Start Date: July 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3% KP-413 Ointment Drug: KP-413 Ointment
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.
Experimental: 1% KP-413 Ointment Drug: KP-413 Ointment
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.
Placebo Comparator: Placebo Drug: KP-413 Ointment
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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932074

Locations
United States, Michigan
Michigan Center for Research Corp
Clinton Twp., Michigan, United States, 48038
United States, Oregon
Oregon Medical Research Center, PC
Portland, Oregon, United States, 97223
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
College Station, Texas, United States, 77845
Dermatology Treatment & Research Center, PA
Dallas, Texas, United States, 75230
United States, Virginia
The Education & Research Foundation, Inc
Lynchburg, Virginia, United States, 24501-1604
Sponsors and Collaborators
Kaken Pharmaceutical
Dow Pharmaceutical Sciences
Investigators
Study Director: Barry Calvarese, MS Dow Pharmaceutical Sciences
  More Information

No publications provided

Responsible Party: Kaken Pharmaceutical
ClinicalTrials.gov Identifier: NCT00932074     History of Changes
Other Study ID Numbers: DPSI-KP413-P2-01
Study First Received: June 30, 2009
Last Updated: April 4, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Kaken Pharmaceutical:
Atopic Dermatitis

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on November 27, 2014