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Completed

NCT Number: NCT00932074

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

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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Michigan Center for Research Corp, Clinton Twp., Michigan, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

KP-413 Ointment

Drug

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 outcomes

  1. Investigator's Global Severity Score(IGSS)

    Time frame: 4 weeks

Secondary outcomes

  1. Plasma levels of KP-413

    Time frame: 6 weeks

  2. Signs and Symptoms of AD

    Time frame: 4 weeks

  3. Subject's Numerical Rating Scale(NRS) of Pruritus Score

    Time frame: 4 weeks

  4. Percent of AD-affected body surface area (BSA)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Kaken Pharmaceutical

Industry

Collaborators

  • Dow Pharmaceutical Sciences

Registry information

Official study title

A Phase 1/2 Study Evaluating the Safety, Tolerability and Efficacy of KP-413 Topical Ointment in Subjects With Atopic Dermatitis

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2009
Registry last updated
Apr 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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