NCT02031445.
| Study characteristics | |
| Methods | Trial design: randomised, quadruple‐blinded (participant, care provider, investigator, outcomes assessor), multicentre, parallel study Trial registration number: NCT02031445 Country: Israel Outpatient or hospital: several dermatology clinics Date trial conducted: August 2014 to March 2015 Duration of trial participation: 4 weeks (assumed) Inclusion criteria: · ≥ 2 and ≤ 17 years of age, of any race or ethnicity · Mild‐to‐moderate AD, IGA score of 2 or 3 according to Hanifin and Rajka, Rothe 1980 criteria, ≥ 3 months prior · ≥ 5% total body surface area Exclusion criteria: · TSC within 7 days of the study · Systemic corticosteroids, topical calcineurin inhibitors, phototherapy or immunosuppressive therapy within 14 days · Requirement for systemic treatment of AD · Systemic anti‐infective or antibiotic treatment within 14 days of the study · Clinical conditions other than atopic dermatitis that may interfere with the evaluation · Secondary infection of atopic dermatitis within the target area or open skin infections in any area · Pregnancy or breastfeeding · History of sensitivity or to any component of the study medication · History of severe anxiety and/or depression; or suicide attempt · HIV · Laboratory result outside the normal range that is clinically relevant · Participation in any other trial within 6 weeks of the study · Chronic condition(s) which are unstable or uncontrolled · Use of non‐sedating antihistamines during or within 7 days of the study · Drug or alcohol abuse, mental dysfunction, or other condition limiting the subject's ability to be compliant with study requirements Additional design details: none |
| Participants | Total number randomised: 73 participants Age: ≥ 2 and ≤ 17 years of age Sex: any Ethnicity: any Duration of eczema: ≥ 3 months Severity of eczema: IGA score of 2 or 3 corresponding to mild/moderate Body site, number of withdrawals: not reported Notes: none |
| Interventions | Run‐in details: not reported Intervention: MRX‐6 2% cream used for 28 days (assumed) · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used 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 · AE |
| Notes | Funding source: Celsus Therapeutics PLC Declarations of interest: not declared Original language of publication: English Other: terminated as interim analysis showed lack of efficacy |