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CompletedNCT00932074Updated Apr 6, 2012

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

A Phase 1/2 interventional study of KP-413 Ointment in Atopic Dermatitis, sponsored by Kaken Pharmaceutical. Completed at 6 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2012-04-06.

Sponsored by Kaken Pharmaceutical · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Atopic Dermatitis

Keywords

  • Atopic Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 58 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Kaken Pharmaceutical is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Experimental
    3% KP-413 Ointment

    Drug: KP-413 Ointment

  • Experimental
    1% KP-413 Ointment

    Drug: KP-413 Ointment

  • Placebo comparator
    Placebo

    Drug: KP-413 Ointment

Interventions

  • DrugKP-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.

06

What researchers measure

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

07

Study locations

6 sites
  • Michigan Center for Research Corp
    Clinton Twp., Michigan 48038, United States
  • Oregon Medical Research Center, PC
    Portland, Oregon 97223, United States
  • DermResearch, Inc.
    Austin, Texas 78759, United States
  • J & S Studies, Inc.
    College Station, Texas 77845, United States
  • Dermatology Treatment & Research Center, PA
    Dallas, Texas 75230, United States
  • The Education & Research Foundation, Inc
    Lynchburg, Virginia 24501-1604, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00932074
Lead sponsor
Kaken Pharmaceutical
Collaborators
Dow Pharmaceutical Sciences
Responsible party
Sponsor
First posted
Jul 2, 2009
Start date
Jul 2009
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Apr 6, 2012

Study contacts

Barry Calvarese, MS
study director · Dow Pharmaceutical Sciences

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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