NCT01567995.

Study name	Randomised, double‐blind, placebo‐controlled study of topical clobetasone butyrate 0.05% cream in subjects with eczema for two weeks to evaluate the efficacy and safety
Methods	Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT01567995 Country: China Outpatient or hospital: not reported Date trial conducted: February 2008 to February 2009 Duration of trial participation: 2 weeks Inclusion criteria: · Diagnosis of eczema, according to: 1) erythema, papilla/water blister, lichenification, skin damage with infiltration, 2) unknown reason, recurrent attacks; 3) itching in diseased skin · BSA disease involvement of less than or equal to 10% as assessed by palm method · Present with moderate and above eczema as defined by a score greater than or equal to 3 using the IGA of eczema severity Exclusion criteria: · Any systemic disorder or active skin disease that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening · Eczema restricted to the face, the feet or the hands only · Any anti‐infective drug for a current complication of overt bacterial, fungal and viral infection · History of recent (< 1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella · Exposure to therapy within the set time frame of: topical agents administered to the diseased skin, including emollient ‐ 1 week; systemic administration of antihistamine agents ‐ 2 weeks; systemic administration of corticosteroids ‐ 4 weeks; systemic administration of immunosuppressive drugs ‐ 4 weeks; UV therapy ‐ 4 weeks · Foreseeable intensive UV exposure during the study. Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices for the duration of the study. · History of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, neurological, renal or haematological abnormalities · History of allergy to components of test medications · History of anaphylaxis to food, medications, insect venom, or latex Additional design details: none
Participants	Total number randomised: 240 participants Age: 12 to 65 years Sex, ethnicity, duration of eczema: not reported Severity of eczema: moderate‐to‐severe eczema defined by IGA score greater than or equal to 3 Body site: not reported Number of withdrawals: not reported Notes: none
Interventions	Run‐in details: not reported Intervention: clobetasone butyrate 0.05% cream for 14 days · Concurrent treatment: not reported · Other key information: Comparator: 0.% used for 14 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none
Outcomes	· Change from baseline in EASI score · Reduction percentage of EASI score after 7 days of treatment
Starting date	2008
Contact information	Not reported
Notes	Funding source: GlaxoSmithKline Declarations of interest: not declared Original language of publication: English Other: none