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

Kaken Pharmaceutical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Atopic Dermatitis

Treatments

Drug: KP-413 Ointment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00932074

DPSI-KP413-P2-01

Details and patient eligibility

About

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).

Enrollment

58 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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.