Hebert 2007b.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind multicentre, parallel study Trial registration number: not reported Country: US Outpatient or hospital, date trial conducted: not reported Duration of trial participation: 28 days Inclusion criteria: · A clinical diagnosis of stable, mild‐to‐moderate AD according to Hanifin and Rajka criteria · Severity of AD according to PGA score of 2 or 3 · A minimum percent surface area involvement of at least 10% BSA Exclusion criteria: not reported Additional design details: To quote: "Two phase III studies of slightly different design were conducted. Both trials were randomized, blinded, vehicle‐controlled trials in which neither the subject nor the investigator knew the identity of the assigned test material. Assignment to treatment arms in these studies included a desonide hydrogel to vehicle ratio of 3 to 1 for the first study and a ratio of 2 to 1 for the second study". |
| Participants | Total number randomised: 201 participants (136 to apply the intervention and 65 to apply the vehicle) Age: between 3 months to 18 years of age Sex: inclusion criteria male or female, no further details Ethnicity: to quote: "of any race" Duration of eczema: to quote: "must have an itchy skin in the last 12 months" Severity of eczema: a minimum disease severity characterised by IGSS of mild‐to‐moderate and individual scores of at least mild for both erythema and induration as defined below (efficacy assessment) Body site: not reported Number of withdrawals: 14 Notes: none |
| Interventions | Run‐in details: not reported Intervention: desonide 0.05% hydrogel (gel) used twice daily for 28 days Concurrent treatment: not reported Other key information: none Comparator: vehicle gel used twice daily for 28 days Concurrent treatment: not reported Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · IGSS · Per cent change from baseline in severity scores for the signs and symptoms of AD · Pruritus severity, and the per cent BSA affected by AD · Safety |
| Notes | Funding source: SkinMedica, Inc. Declarations of interest: corresponding author affiliated to commercial funder SkinMedica Original language of publication: English Other: none |