NCT03386032.
| Study characteristics | |
| Methods | Trial design: randomised, double‐blind, multicentre, parallel study Trial registration number: NCT03386032 Country: USA Outpatient or hospital: not reported Date trial conducted: November 2017 to August 2018 Duration of trial participation: 9 weeks including an 8‐week treatment phase Inclusion criteria: · Otherwise healthy, male or female, aged 12 to 65 years old · Diagnosis of moderate‐to‐severe AD (SCORAD ≥ 25) Exclusion criteria: · Involvement in another clinical trial within the past two weeks · Diagnosed with or treated for cancer within the past 5 years · Requirement for topical or systemic medications that could affect their AD during the study period (except inhaled steroids and/or stable antihistamines for asthma or allergies) · Used systemic treatments within the past 30 days or 5 half‐lives · Known hypersensitivity to corticosteroid creams or other ingredients of the investigational product · Diagnosis with any oat allergies or derivatives · Active infections or antibiotics in the past 7 days · Presence of physical attributes or skin conditions that might interfere with the clear visual or instrumental assessments · Diagnosis of an immunologic or infectious disease which could place the subject at risk or interfere with the accuracy of the study results · Employment by the sponsor company or clinical testing site · Diabetes · Active or chronic allergic reaction evidenced by eosinophils > 0.3 X 109/L on screening · Planned visit to a sunny climate, tanning booths or other UV sources during the study · Pregnancy, lactation, or planning to become pregnant in the next 6 months Additional design details: none |
| Participants | Total number randomised: 65 participants (11 to apply the intervention and 18 to apply the comparator) Age: intervention group, mean 42 years (SD 15.4); comparator group, mean 39.6 years (SD 15.3) Sex: intervention group, 63.6% female; comparator group, 83.3% female Ethnicity: intervention group, 54.5% black, 36.4% white, 9.1% more than one race; comparator group, 50% black, 50% white Duration of eczema: not reported Severity of eczema: SCORAD scores: intervention group, mean 45.33 (SD 4.33); comparator group, 52.21 (SD 3.36) Body site: not reported Number of withdrawals: 7 all in the comparator group due to lack of effect n = 2, AE = 2, lost to follow‐up n = 3 Notes: none |
| Interventions | Run‐in details: one week "washout phase" Intervention: desonide 0.05% cream · Concurrent treatment: placebo cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturiser · Other key information: in the trial the TCS was one of two active interventions. The other active intervention was not specified and data have not been extracted for that arm. Comparator: vehicle cream used twice daily for 8 weeks · Concurrent treatment: not reported · Other key information: none Concurrent treatments received alongside both intervention and comparator: not reported Notes: none |
| Outcomes | · SCORAD of participants with moderate AD · SCORAD of participants with severe AD |
| Notes | Funding source: Procter and Gamble Declarations of interest: not declared Original language of publication: English Other: none |