Del Rosso 2009.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind study Trial registration number: not reported Country: USA Outpatient or hospital, date trial conducted: not reported Duration of trial participation: 2 weeks Inclusion criteria: · Adults with AD · 2 to 10% BSA · Clinically stable for at least one month · Total symptom score ≥ 7 out of 12 based on the investigator’s evaluation (erythema, infiltration/papulation, excoriations, and lichenification of all affected treatable areas scored 0 = none to 3 = severe) · Pruritus score ≥ 1 · IGA ≥ 3 (moderate) · No systemic/dermatological condition that might interfere with the study results or compromise safety Exclusion criteria: · Topical corticosteroids, topical retinoids, or topical calcineurin inhibitors within two weeks of the trial · Systemic corticosteroids, systemic retinoids, or prolonged sun exposure/ultraviolet light therapy within four weeks of the trial Additional design details: none |
| Participants | Total number randomised: 313 participants (211 to apply the intervention and 102 to apply the comparator) Age: TCS once daily group mean 40.9 years (SD 13.0) range 19 to 76; TCS twice daily group 42.9 years (SD 15.7), range 18 to 79; vehicle once daily 43.7 years (SD 16.5), range 18 to 76; vehicle twice daily group 43.7 years (SD 13.0), range 20 to 71 Sex: male n = 136, female n = 173 Ethnicity: Caucasian n = 243, African‐American n = 44, Asian n = 7, Hispanic n = 27, native American n = 2 Duration of eczema: mean: TCS once daily group, 17.2 years (SD 14.6), range 0.1 to 52; TCS twice daily group, 17.8 years (SD 16.8) range 0.9 to 64; vehicle one daily group, 16.8 years (SD 16.5) range 0.9 to 62; vehicle twice daily group, 17.2 years (SD 15.1), range 1.0 to 57) Severity of eczema: people with moderate eczema were eligible. Body site: not reported Number of withdrawals: to quote: "Twenty‐two subjects discontinued the study for the following reasons: AE (n = 5; 1.6%), protocol violation (n = 1; 0.3%), subject’s request (n = 5; 1.6%), lost to follow‐up (n = 9; 2.9%), and other reasons (n = 2; 0.6%)" Notes: none |
| Interventions | Run‐in details: four weeks required for any medication known to affect serum cortisol levels or HPA axis function for subjects undergoing HPA evaluation Intervention: fluocinonide 0.1% cream used once or twice daily for 14 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used once or twice daily for 14 days. · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · Overall severity on a 5‐point scale · Severity of erythema, infiltration/papulation, excoriations, and lichenification · Pruritus · BSA · AE · HPA axis suppression |
| Notes | Funding source: not reported Declarations of interest: To quote: "Dr. Del Rosso is a consultant, speaker, and/or researcher for Allergan, Coria, Galderma, Graceway, Intendis, Medicis, Onset Therapeutics, Obagi Medical Products, Ortho Dermatology, PharmaDerm, Quinnova, Ranbaxy, SkinMedica, Stiefel, Triax, Unilever, and Warner‐Chilcott. Dr. Bhambri reports no relevant conflicts of interest." Original language of publication: English Other: none |