Nakagawa 2018b.
| Study characteristics | |
| Methods | Trial design: randomised, parallel study Trial registration number: not reported Country: Japan Outpatient or hospital, date trial conducted: not reported Duration of trial participation: 8 days Inclusion criteria: adults with AD Exclusion criteria: not reported Additional design details: none |
| Participants | Total number randomised: 20 participants (8 to apply intervention one, 8 intervention two, and 4 TO apply the comparator) Age: mean: vehicle group: 24.8 years (SD 5.6) range 21 to 33; 1% group: 26.5 years (SD 5.4) range 21 to 33; 3% group: 30 years (SD 8.2) range 21 to 43 Sex: male n = 18, female n = 2 Ethnicity: all participants were Japanese. Duration of eczema: mean duration: vehicle group, 18.8 years (SD 10.8); 1% group, 20.3 years (SD 9.2); 3% group, 26.4 years (SD 7.3) Severity of eczema: vehicle: moderate n = 14; severe n = 6, 0, based on EASI and IGA scores Body site: not reported Number of withdrawals: one due to personal reasons (in 3% group) Notes: none |
| Interventions | Run‐in details: not reported Intervention one: delgocitinib 1% ointment used twice daily for 7 days · Concurrent treatment: not reported · Other key information: none Intervention two: delgocitinib 3% ointment used twice daily for 7 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle ointment used twice daily for 7 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator; rescue medication of hydrocortisone butyrate ointment 0.1% could be used for the treatment of worsening of AD. Notes: 1% and 3% JTE‐052 ointments were applied in the morning and the evening with a 12‐hour interval in a stepwise approach with two different dose groups. 5 g of JTE‐052 was applied to the areas affected by inflammatory eczema, excluding the head, neck, palm, sole, groin and genitals. The application area had to be the same throughout the study and JTE‐052 ointment was removed in the morning on day 8. The study did not report that this was undertaken in the same way for the placebo group, but we assumed that it was. |
| Outcomes | · Safety · Efficacy using IGA, EASI and pruritus · |
| Notes | Funding source: Japan Tobacco Inc. Declarations of interest: one author was a consultant and/or has received research grants and/or honoraria from Japan Tobacco Inc., LEO Pharma and Maruho Co. Ltd; another has received honoraria from Japan Tobacco Inc and two were employees of Japan Tobacco Inc. Original language of publication: English Other: none |