Breneman 2005.

Study characteristics
Methods	Trial design: randomised controlled, multicentre study Trial registration number: not reported Country: US Outpatient or hospital, date trial conducted: not reported Duration of trial participation: 4 weeks Inclusion criteria: · Male or female with stable moderate‐to‐severe AD · DSS of erythema, excoriation and induration/papulation, of at least 6 in the target area · at least 3 of the following: pruritus, flexural lichenification, linearity in adults with a variety of skin lesions, chronic or chronically‐relapsing dermatitis · Personal or family history of atopy (asthma, allergic rhinitis, AD) Exclusion criteria: · Concomitant medical or dermatologic disorders precluding accurate evaluation of AD · Using interfering concomitant therapies · Known sensitivities to any ingredients of the study treatments Additional design details: none
Participants	Total number randomised: 229 participants Age: intervention (lotion) mean 39.3 years (SD 19); intervention (emollient) mean 42.4 years (SD 17.8); vehicle group mean 40.7 years (SD 19.4) Sex: intervention group males n = 84, females n = 112; vehicle group males n = 15, females n = 18 Ethnicity: intervention group: white n =136, black n = 39, oriental n = 7, Hispanic n = 10, other n = 4; vehicle group: white n = 23, black n = 8, oriental n = 0, Hispanic n = 2, other n = 0 Duration of eczema: intervention group 1 to 880 months; vehicle group 6 to 429 months Severity of eczema: moderate‐to‐severe eczema was eligible Body site: not reported Number of withdrawals: 23 of which 16 were receiving active treatment and 7 vehicle. Subject request and loss to follow‐up were the major reasons for discontinuation of participants receiving treatment. In the placebo group, one discontinued due to an adverse event. Notes: none
Interventions	Run‐in details: specific washout periods were to be respected for topical and systematic AD treatments. Intervention one: clobetasol propionate 0.05% lotion used twice daily for 14 days · Concurrent treatment: not reported · Other key information: none Intervention two: clobetasol propionate 0.05% cream used twice daily for 14 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle lotion used twice daily for 14 days · Concurrent treatment: not reported · Other key information: one Concurrent treatments received alongside both intervention and comparator: not reported Notes: none
Outcomes	· Global Severity scale · Dermatologic Sum Score (DSS) · Safety
Notes	Funding source: Galderma Medical Affairs, Inc Declarations of interest: authors included employees of Galderma R&D, those receiving honoraries for participating in this trial or project funding from the company. Original language of publication: English Other: Outcome data were more complete at 2 weeks follow‐up than at end of follow‐up (at 4 weeks).