EUCTR2011‐000917‐38‐DE.
| Methods | Trial design: randomised, double‐blind, multicenter, study Trial registration number: EUCTR2011‐000917‐38‐DE 2011/NCT01428297 Country: US, Germany, France, Netherlands Outpatient or hospital: 17 centres in the United States, Germany, France, and Netherlands Date trial conducted: May 2011 to February 2014 Duration of trial participation: 4 weeks Inclusion criteria: · Male and female, 18 to 65 years · Presence of AD confirmed by itchy skin condition in the past 12 months (must have) Plus three or more of the following: ‐ history of involvement of skin creases ‐ personal history of asthma or hay fever ‐ history of generally dry skin in the past year ‐ onset before age of 2 years ‐ visible flexural dermatitis · Diagnosis of at least moderate AD by the IGA and a minimum target area (right or left) situated on the forearm including the antecubital fossa with a corresponding baseline TLSS Exclusion criteria: · History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes or history of serious allergic reaction · History of abnormal skin reactivity to UV light. Unusual exposure to UV light in the previous 3 weeks of study start, including tanning and sun beds · Pregnant or lactating women · Women of childbearing potential must use highly effective contraception. · Use of topical prescription treatment for eczema within 1 week prior to initial dosing of TCS · Recent previous treatment with systemic treatment including phototherapy. A washout period will be required for such patients to be eligible to participate in the trial. Additional design details: the study involved 3 cohorts of which only one was relevant to this review ("Healthy volunteers for Part 1, subjects with AD for Part 2 and subjects with Netherton Syndrome (NS) for Part 3") |
| Participants | Total number randomised: 49 participants (25 to apply the intervention and 24 to apply the comparator) Age: mean 35 years (SD 13.1), range from 18 to 64 Sex: 49% male, 51% female Ethnicity: 80% Caucasian, 10% black, 6% Asian, 4% other Duration of eczema, severity of eczema, body site: not reported Number of withdrawals: 1 Notes: |
| Interventions | Run‐in details: not reported Intervention: BPR277 1.% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: intervention of unknown mode Comparator: 0.% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · AE · TLSS was assessed each week for the treatment areas. |
| Notes | Funding source: Novartis Pharma AG Declarations of interest: not declared Original language of publication: English Other: results of the study are available but not extracted as we did not know the intervention's mode of action. Unclear if the intervention is an anti‐inflammatory |