Lawlor 1995.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, single‐centre, parallel study Trial registration number: not reported Country: UK Outpatient or hospital: clinics at St John's Hospital, including the contact dermatitis clinic when patch testing was negative Date trial conducted: not reported Duration of trial participation: 28 days Inclusion criteria: · Mild‐to‐moderate eczema · At least 10% involvement · Included hands, epigastrium, shoulder/thorax, lower leg, thigh/knee, head or neck, abdomen or feet · Age 18 to 60 Exclusion criteria: · Facial eczema, exudative, infected, and widespread (> 50%) · Oral corticosteroids 4 weeks prior · Concomitant serious disease · Female and not on adequate contraception · Severe involvement in either scratch marks, erythema, scaling, lichenification, vesiculation, and hyperkeratosis Additional design details: none |
| Participants | Total number randomised: 51 participants (24 to apply the intervention and 27 to apply the comparator) Age: 17 to 68 years Sex: female or male Ethnicity: not reported Duration of eczema: 0.3 to 28 years Severity of eczema: mild‐to‐moderate Body site: hands, epigastrium, shoulder/thorax, lower leg, thigh/knee, head or neck, abdomen Number of withdrawals: 6 due to, to quote "not making sufficient progress". 5 from control, 1 from treatment. A further 13 had treatment stopped by the doctor because of lack of progress, AE, or infection. Notes: none |
| Interventions | Run‐in details: not reported Intervention: prednicarbate 0.25% ointment used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Comparator: vehicle used twice daily for 28 days · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: avoid using soap and use aqueous cream BP as soap substitute. Treatment was discontinued at any visit at which eczema was clear. Notes: none |
| Outcomes | · Clinician‐reported signs: "physical signs of excoriation, erythema, scaling, lichenification and vesiculation recorded on a scale of 1 to 5 (1 = none, 5 = very severe)" · Patient‐reported signs: pruritis on a VAS · AE · IGA (excellent, good, fair, poor, exacerbation) · Patient‐reported signs: patient global evaluation (excellent, good, fair, poor, exacerbation) · Clinician/patient‐reported signs: overall efficacy, tolerability, cosmetic acceptability ‐ investigator and patient assessment |
| Notes | Funding source: not reported Declarations of interest: one author supported by Hoechs Ag, Germany (suppliers of intervention) Original language of publication: English Other: none |