Woods 2011.
| Study characteristics | |
| Methods | Trial design: randomised, single‐centre study Trial registration number: NCT00819507 Country: USA Outpatient or hospital: outpatient university‐based dermatology clinic Date trial conducted: January 2009 to June 2010 Duration of trial participation: 2 weeks Inclusion criteria: · 12 years of age or older with AD according to Hanifin‐Rajka criteria · IGA of moderate, severe, or very severe · Failed to achieve adequate disease control despite appropriate topical or systemic therapy · A candidate, according to the principal investigator, for a super‐potent topical steroid course Exclusion criteria: · Active skin infection · Hypersensitivity to any ingredients in fluocinonide 0.1% cream · Previous use of super‐potent topical steroids within two weeks of starting study (class I steroid) · Current use of systemic therapy, unless on stable doses for at least three months Additional design details: none |
| Participants | Total number randomised: 50 sides treated (25 to apply the intervention and 25 to apply the comparator) Age: mean 39 years (range 17 to 67) Sex: female n = 14, male n = 11 Ethnicity: Hispanic n = 1, mixed n = 1, Asian n = 2, African‐American = 2, Caucasian n = 19 Duration of eczema: not reported Severity of eczema: moderate‐to‐severe AD according to Hanifin‐Rajka criteria Body site: target areas could not be chosen from the hands, feet, face or genital area. Number of withdrawals: there were no withdrawals. Notes: none |
| Interventions | Run‐in details: there was no washout period required for use of class II or less potent topical steroids, representing a typical clinical scenario in which patients use progressively more potent topical steroids to achieve disease control. Intervention: fluocinonide 0.1% cream used once daily for 14 days or until clear · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used once daily for 14 days or until clear · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: systemic therapy (including phototherapy) for AD was allowed only if the subject was on stable doses for at least three months. Topical antipruritics or topical anti‐inflammatory medications were not permitted during the study, but required no washout. The use of emollients (only Cetaphil™ cream, Aquaphor™, plastibase, or petrolatum) was permitted during the study, but not for eight hours prior to measurements. The use of antibiotics (topical or oral) or antihistamines was permitted during the study. Participants continued all other oral medications needed for stable medical problems. Notes: none |
| Outcomes | · Basal trans‐epidermal water loss in acute lesional skin · Change in skin capacitance · EASI score · Pruritus VAS · Quality of life · IGA |
| Notes | Funding source: Medicis Pharmaceutical Corporation Declarations of interest: three authors had no relevant conflicts of interest to disclose. Another author received a research grant from Medicis Pharmaceuticals for this project, and has served as consultant to and received honorariums from various pharmaceutical companies. Original language of publication: English Other: none |