NCT00932074.
| Methods | Trial design: randomised, controlled, parallel, triple‐blind, study Trial registration number: NCT00932074 Country: US Outpatient or hospital: not reported Date trial conducted: July 2009 to June 2010 Duration of trial participation: not reported Inclusion criteria: · Male or female aged 18 years to 64 years · AD meeting the Hanifin and Rajka criteria for AD that involves both the head/neck and the torso/limbs, and affects 5 to 30% of the subject's total BSA as determined using the rule of nines · 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 · Oozing/crusting score of 3 (moderate) or greater at the selected treatment area on the head/neck or torso/limbs · 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 Additional design details: none |
| Participants | Total number randomised: 58 participants Age, sex, ethnicity, duration of eczema, severity of eczema, body site, number of withdrawals: not reported Notes: study results not provided |
| Interventions | Run‐in details: not reported Intervention one: KP413 3% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: KP413 ‐ classed as an anti‐inflammatory whose mechanism of action is as an immunomodulator (Adis Insight Springer) Intervention two: KP413 1% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: 0.% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · IGSS time frame: 4 weeks · Plasma levels of KP‐413 · Signs and symptoms of AD, time frame: 4 weeks · Subject's NRS of Pruritus Score, time frame: 4 weeks · Per cent of AD‐affected BSA, time frame: 4 weeks |
| Notes | Funding source: Kaken Pharmaceutical Dow Pharmaceutical Sciences Declarations of interest: not reported Original language of publication: English Other: unclear if the intervention is an anti‐inflammatory |