Hanifin 2016.
Study characteristics | |
Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT02068352 Country: USA, Australia, Poland Outpatient or hospital: presumed outpatient Date trial conducted: June 2014 to February 2015 Duration of trial participation: 8 weeks Inclusion criteria: · Aged between 10 and 70 years · AD according to Hanifin and Rajka, and Rajka and Langeland criteria · IGA score of 2 (mild) or 3 (moderate) · At least a 3‐year history of the disease · BSA affected by AD at baseline could not be more than 40%, but had to be at least 5. · The face, neck, and head were not treated under the protocol. · Patients were required to have had a previous positive but inadequate response to 1 or more standard therapies for AD or were currently unable to use a previously successful treatment. Exclusion criteria: · Having received systemic therapy or phototherapy within 28 days · Use of TCS or calcineurin inhibitors within 7 days of study entry Additional design details: none |
Participants | Total number randomised: 121 participants (41 to apply intervention one, 43 to apply intervention two, and 37 to apply the comparator) Age: 10 to 70 years, mean 34.3 (SD 15.8) Sex: male 40.4%, female 59.5% Ethnicity: white 67.7%, black/African‐American 24.8%, Asian 3.3%, American‐Indian/Alaskan native 0.8%, Pacific Islander 2.5%, unknown 0.8% Duration of eczema: at least 3‐year history Severity of eczema: mild‐to‐moderate Body site: whole body excluding head, neck, face Number of withdrawals: 27, vehicle group n = 9; 0.3% OPA group n = 10; 1% OPA group n = 8 Notes: none |
Interventions | Run‐in details: none Intervention one: OPA‐15406 0.3% ointment used twice daily for 8 weeks · Concurrent treatment: not reported · Other key information: none Intervention two: OPA‐15406 1% ointment used twice daily for 8 weeks · Concurrent treatment: not reported · Other key information: none Comparator: vehicle 0% ointment used twice daily for 8 weeks · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
Outcomes | · Percentage of participants with success in the IGA score · Change from baseline in overall IGA score · Percentage of participants with AE · Change from baseline in EASI score · Change from baseline in VAS score for pruritus |
Notes | Funding source: Otsuka Pharmaceuticals and Commercialization, Inc. Declarations of interest: not declared Original language of publication: English Other: none |