This study will investigate the steroid sparing potential of DS107E to vehicle in patients with moderate to severe atopic dermatitis. DS107E or vehicle will be topically administered with a steroid twice a day for the first 7 days. For the following 56 days DS107E or vehicle will be topically administered twice a day. This study will enrol approximately 40 paediatric patients.
Patients will come to the clinic on 8 occasions: Screening, Baseline, Day 7, Day 21, Day 35, Day 49, Day 63 (End of Treatment) and Day 91 (Follow-up). The primary efficacy variables will be IGA (Investigator Global Assessment) and SCORAD (SCORing Atopic Dermatitis) . The secondary efficacy variables will be IGA, SCORAD, EASI (Eczema Area and Severity Index), IDQOL (Infant Dermatology Quality of Life), DFI (Dermatitis Family Impact), BSA, TEWL (Transepidermal Water Loss) and Time to Rescue Medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
DS Biopharma Investigational Site
Dublin, Ireland
Investigator Global Assessment
Time frame: 9 weeks
SCORing Atopic Dermatitis
Erythema, population, oozing, excoriation, lichenification, dryness, body surface area, sleep loss and pruritus is all graded. The sum of the above measures represent the SCORAD which can vary from 0 to 103.
Time frame: 9 weeks
Investigator Global Assessment
Time frame: Days 7, 21. 35. 49, 63
Eczema Area and Severity Index
Proportion of patients achieving a reduction in EASI score
Time frame: Days 7, 21. 35. 49, 63
Body Surface Area
Time frame: Days 7, 21. 35. 49, 63
Trans-Epidermal Water Loss
Time frame: Days 63
Time to Rescue Medication
Time frame: 9 weeks
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