NCT02496546.
| Study name | An explorative trial evaluating the effect of LEO 32731 cream in adults with mild to moderate atopic dermatitis |
| Methods | Trial design: randomised, parallel study Trial registration number: NCT02496546 Country: Germany Outpatient or hospital: Proinnovera GmbH, Center of Dermatology Excellence, Münster Date trial conducted: July 2015 to March 2016 Duration of trial participation: 3 weeks Inclusion criteria: · Males ≥ 18 years · AD according to Hanifin and Rajka criteria and with mild‐to‐moderate disease severity (IGA 2 or 3) · Two symmetrically located and comparable target areas of 20 to 50 cm2 each, i.e. on the same body region (left and right part) · TSS ≥ 5 on both target areas with difference < 2 between them, sign score for erythema ≥ 2 on both target areas, and difference in investigator's assessment of severity ≤ 1 between them Exclusion criteria: Any other condition in the treatment areas that could interfere with clinical assessments, e.g. acne, infection, rash, sunburn, hyper‐ or hypopigmentation, or scars Additional design details: none |
| Participants | Total number randomised: 30 participants Age: not reported Sex: male Ethnicity, duration of eczema, severity of eczema, body site, number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: not reported Intervention: orismilast 2.% cream used for 21 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used for 21 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · Individual sign scores (4‐point scale) of erythema, oedema/papulation, oozing/crusting, excoriations, lichenification and dryness for each area · Total sign score: sum of individual sign scores · Investigator's assessment of disease severity |
| Starting date | 2015 |
| Contact information | Not reported |
| Notes | Funding source: LEO Pharma Declarations of interest: not declared Original language of publication: English Other: unclear if the intervention is an anti‐inflammatory |