Sears 1997.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: not reported Country: USA Outpatient or hospital: assumed outpatient Date trial conducted: not reported Duration of trial participation: 14 days Inclusion criteria: disease severity determined by the total score of 7 signs (infiltration, scaling, erythema, lichenification, vesicles, papules, and excoriation) evaluated on a 4‐point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Total score of > 6 required for randomisation Exclusion criteria: · Concurrent diagnosis of an acute systemic illness, including convalescence, severe hepatic disease, or severe renal impairment · Suspected viral, bacterial, or fungal infection of the skin areas selected for treatment · Systemic treatment within the month preceding the trial · Concomitant systemic treatment that might affect the clinical status of the lesions · Known hypersensitivity to or intolerance for topical corticosteroids or any of the ingredients of the study preparations · Pregnant or lactating women or women of childbearing potential who were not using effective contraception Additional design details: none |
| Participants | Total number randomised: 194 participants (121 to apply the intervention and 73 to apply the comparator) Age: average 37.7 years (range 17 to 76) Sex: female n = 107; male = 87 Ethnicity: not reported Duration of eczema: treatment group 10.8 years (SD 12.7); placebo group 11.6 years (SD 15 years) Severity of eczema: treatment group, mild = 18.3%, moderate = 69.2%, severe = 12.5%; placebo group, mild = 15.1%, moderate = 63%, severe = 21.9% Body site: treatment areas of approximately 15% of body surface on the basis of location, size and severity. Treatment areas did not include the face, hands, groin or axillae. Number of withdrawals: 26 withdrawals, 15 treatment group; 11 placebo group Notes: none |
| Interventions | Run‐in details: use of the following medications was a disqualification: topical corticosteroids within 2 weeks of the study; retinoids, intralesional or repository corticosteroids, or long‐acting antihistamines (half‐life > 24 hours) within 4 weeks of the study; or any investigational drug within 1 month of the study Intervention: hydrocortisone buteprate 0.1% cream used once daily for 14 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used once 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 | · Mean lesion score (7‐point signs score) · Investigator rating of overall improvement at each efficacy level · % patients receiving good/excellent efficacy · Patient evaluation of cosmetic qualities of treatment · Safety and tolerability assessment |
| Notes | Funding source: Savage Laboratories, Melville, New York Declarations of interest: not declared Original language of publication: English Other: none |