None listed
Conditions
Brief summary
Atopic eczema is a chronic relapsing skin condition that affects 5 to 20% of children under the age of 10. Eczema can affect the quality of life of the children and their parents/caregivers as well as being a financial burden to families and the health care system. We aim to compare the efficacy of Epaderm ointment with that of a standard ointment in decreasing the severity of eczema in 50 children under the age of 5. We will measure eczema severity using validated SCORAD and EASI scoring systems and by taking infrared photographs of the skin (to measure erythema). We will also take swab samples of the affected and unaffected skin at the start and the end of the trial to determine if the microbiota of the skin is affected by 1] eczema and 2] the different ointments.
Interventions
Randomised single subject double-blind parallel superiority trial of two emollients: Epaderm ointment (active ingredient Cetomacrogol Emulsifying Wax BP) and Emulsifying ointment (BP)(active ingredient white soft paraffin and liquid paraffin) . Each emollient will be randomly assigned for application to one or other side (sagittal plane) of the body as required, but at least once a day, on the affected area for 8 weeks.. Each emollient will always be applied to the same side and will be clearly
Randomised single subject double-blind parallel superiority trial of two emollients: Epaderm ointment (active ingredient Cetomacrogol Emulsifying Wax BP) and Emulsifying ointment (BP)(active ingredient white soft paraffin and liquid paraffin) . Each emollient will be randomly assigned for application to one or other side (sagittal plane) of the body as required, but at least once a day, on the affected area for 8 weeks.. Each emollient will always be applied to the same side and will be clearly marked “for use of XXX (child in study) only” and “for use on left side only” or “for use on right side only”. Parents will be asked to record if they have mistakenly applied the emollient to the wrong side in the study diary and will be asked to bring both containers of study emollient to every clinic visit (week 2, 4, 6 and 8) so they can be weighed by the study staff.
Sponsors
Capital and Coast District Health board
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
No minimum to 5 Years
Healthy volunteers
No
Inclusion criteria
a) Eczema with a severity on SCORAD of greater or equal to 5 for objective measures only b) Children with eczema aged 0-5 c) Parent/caregiver must be able to speak enough English to understand the trial and be able to complete the trial diary
Exclusion criteria
a) Other serious chronic disease that may require immunosuppressive therapy, as decided on a case by case basis by the principal investigator. b) Use of systemic antibacterial therapy within one week prior to starting study treatment c) Patients with co-morbid conditions that would require long term systemic corticosteroid therapy during study treatment. Systemic steroid use for less or equal to 5 days for another reason such as asthma is permissible. d) Severe eczema requiring regular use of potent topical steroids e) Family unable to comply with study requirements as judged by the investigator, such as the desire to use other non-study eczema medications unless medically indicated f) Use of potent topical steroids within one month of enrolment (e.g. mometasone, betamethasone, fluticasone, clobetasol)
Outcome results
None listed