Saeki 2022b.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre study Trial registration number: NCT03908970 Country: Japan Outpatient or hospital: 30 investigational sites Date trial conducted: March 2019 to December 2019 Duration of trial participation: none Inclusion criteria: · Male or female aged 15 to 70 years · AD diagnosed according to the diagnostic criteria of the Japanese Dermatological Association · AD for at least 3 years · IGA score of mild‐to‐moderate · BSA of 5 to 40% (excluding scalp) Exclusion criteria: · Pregnant, possibly pregnant, or breastfeeding, who desire to become pregnant or to have their partner become pregnant or who are unable to either remain abstinent or employ at least two of the specified birth control methods · AD or contact dermatitis flare‐up defined as a rapid intensification of AD, within 28 days prior to the baseline examination · Concurrent or history of skin disease other than AD and who are judged inappropriate for assessment of AD in the present trial · Active or clinical signs of viral skin infection · Current or history of malignancy within the previous 5 years · Current or history of recurrent bacterial infection resulting in hospitalisation or requiring intravenous antibiotic treatment within the past 2 years · Clinically significant complication or history of: cardiac disease, endocrinologic disease, pulmonary disease, neurologic disease, psychiatric disease, hepatic disease, renal disease, haematologic disease, immunologic or immunocompromised disease · Other major disease or other severe uncontrolled condition · Abnormal haematology or serum chemistry · Clinically abnormal blood pressure or pulse rate · Unable to stop allergen immunotherapy (or desensitisation therapy) from 3 months prior · Unable to stop treatment with ultraviolet A, narrowband ultraviolet B, and ultraviolet B from 28 days prior · Unable to stop using systemic corticosteroids, immunosuppressants, antimetabolites, or retinoids, and biologics from 28 days prior · Unable to stop using very strong or higher potency topical corticosteroids for skin (excluding scalp) · Unable to continue in the trial without changing the dosage and administration of systemic antihistamines, sodium cromoglycate, tranilast, or suplatast tosilate from 7 days prior · Hypersensitivity (including history) to any drugs or any ingredient of study drug ointment · Used any other investigational drug within 4 months · Does not respond to treatment with existing topical drugs for AD Additional design details: none |
| Participants | Total number randomised: 364 participants (182 to apply the intervention and 182 to apply the comparator) Age: mean: intervention group 31.7 years (SD 10.9); comparator group 32.1 years (SD 10.6) Sex: intervention group 55.5% male; comparator group 52.7% male Ethnicity: not reported Duration of eczema: intervention group 24.6 years (SD 11.3); comparator group 25 years (SD 11.1) Severity of eczema: intervention group: mild 6.6%, moderate 76.4%, severe 17%, very severe 0%; comparator group: mild 5.5%, moderate 76.9%, severe 16.5%, very severe 1.1% Body site: not reported Number of withdrawals: 63: intervention group 9.3%; comparator group 25.8% Notes: none |
| Interventions | Run‐in details: not reported Intervention: difamilast 1% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: placebo/vehicle 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 | · IGA · EASI · Verbal rating scale for pruritus · POEM · Skindex‐16 score · BSA · Safety |
| Notes | Funding source: Otsuka Pharmaceutical Co Ltd. Declarations of interest: One author has received consultation fees from Otsuka Pharmaceutical Co, Ltd. Several authors are employees of Otsuka Pharmaceutical Co, Ltd. Original language of publication: English Other: none |