NCT01702181.
| Study characteristics | |
| Methods | Trial design: randomised, quadruple‐blinded (participant, care provider, investigator, outcomes assessor), parallel study Trial registration number: NCT01702181 Country: USA Outpatient or hospital: not reported Date trial conducted: August 2012 to December 2013 Duration of trial participation: 28 days Inclusion criteria: · Adult 18 to 65 years of age · AD affecting ≥ 5% BSA for part 1 and ≥ 10% BSA for part 2 (excluding face, neck, and head) · Has a positive but inadequate response to standard AD therapy including topical steroids or phototherapy Exclusion criteria: use of systemic or topical therapy for contact or atopic dermatitis within 30 days of the trial Additional design details: the phrase "sequential dose cohorts" was used, but no detail was given. |
| Participants | Total number randomised: 92 participants Age: 18 to 65 years Sex: all Ethnicity, duration of eczema, severity of eczema: not reported Body site: excluding face, neck and head Number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: not reported Intervention one: difamilast 0.3% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Intervention two: difamilast 1% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Intervention three: difamilast 3% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: tacrolimus 0.1% 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 | · Number of subjects with AE, and% of clinically relevant changes from baseline in Draize Scale, physical examinations, vital signs, laboratory assessments, and electrocardiograms · Measurement of drug levels in the blood · IGA |
| Notes | Funding source: Otsuka Pharmaceutical Development & Commercialization, Inc. Declarations of interest: not declared Original language of publication: English Other: none |