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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932074
• Other study ID #: DPSI-KP413-P2-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 30, 2009
• Last updated: April 4, 2012
• Start date: July 2009
• Est. completion date: June 2010

Study information

• Verified date: April 2012
• Source: Kaken Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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.

Locations

Country	Name	City	State
United States	DermResearch, Inc.	Austin	Texas
United States	Michigan Center for Research Corp	Clinton Twp.	Michigan
United States	J & S Studies, Inc.	College Station	Texas
United States	Dermatology Treatment & Research Center, PA	Dallas	Texas
United States	The Education & Research Foundation, Inc	Lynchburg	Virginia
United States	Oregon Medical Research Center, PC	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Kaken Pharmaceutical	Dow Pharmaceutical Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigator's Global Severity Score(IGSS)		4 weeks	No
Secondary	Plasma levels of KP-413		6 weeks	Yes
Secondary	Signs and Symptoms of AD		4 weeks	No
Secondary	Subject's Numerical Rating Scale(NRS) of Pruritus Score		4 weeks	No
Secondary	Percent of AD-affected body surface area (BSA)		4 weeks	No