Tharp 1996.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number, country: not reported Outpatient or hospital: to quote: "study centers" Date trial conducted: August to December 1999 Duration of trial participation: 4 weeks Inclusion criteria: · 12 years or older · Established diagnosis of eczema Exclusion criteria: · Lesions of the scalp, face, axillae, and groin were not chosen as the target lesion. · Prescribed medications with associated washout periods · Interfering disease states · Sensitivity to ingredients of the study medication or other optical or systemic steroid therapy · Acute self‐limited eczema or whose eczema is likely to improve spontaneously Additional design details: the study has 3 group comparisons; for the purposes of this review, we have combined the groups that evaluated the treatment drug as either once or twice a day. |
| Participants | Total number randomised: 238 participants (158 to apply the intervention and 80 to apply the comparator) Age: intervention group, mean 38 years, range 14 to 82; comparator group, mean 36 years, range 12 to 87 Sex: M:F, intervention group: 104:54 comparator group: 56:24 Ethnicity: white n = 162, black n = 37, Asian n = 15, other n = 24 Duration of eczema: median 11 years, range from 0 to 71 years Severity of eczema: n = 152 worsening, n = 85 stable moderate‐to‐severe Body site: lesions of the scalp, face, axillae, and groin were not chosen as the target lesion. Number of withdrawals: 55: intervention group n = 33, comparator group n = 22 Notes: none |
| Interventions | Run‐in details: not reported Intervention: fluticasone propionate 0.05% cream used once daily or twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle cream used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: occlusive dressings were not used. No other treatments or medications for eczema were to be used. Notes: none |
| Outcomes | · IGA binary · Patients' subjective assessment · Clinician‐reported signs (continuous) · AE |
| Notes | Funding source: not reported Declarations of interest: not declared Original language of publication: English Other: none |