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. 2024 Aug 6;2024(8):CD015064. doi: 10.1002/14651858.CD015064.pub2

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