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 28 days DS107E or vehicle will be topically administered twice a day. This study will enrol approximately 40 adult patients.
Subjects will come to the clinic on 7 occasions: Screening, Baseline, Day 7, Day 14, Day 21, Day 35 (End of Treatment) and Day 42 (Follow-up). The primary efficacy variable will be EASI (Eczema Area and Severity Index). The secondary efficacy variables will be EASI, IGA (Investigators Global Assessment), SCORAD (SCORing Atopic Dermatitis), Target Lesion Score, VAS (Visual Analogue Scale), Skin Tolerability, DLQI (Dermatology Life Quality Index), Erythema, TEWL (Transepidermal Water Loss) and Time to Rescue Medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
42
DS Biopharma Investigational Site
Lübeck, Germany
Eczema Area and Severity Index (EASI)
Four anatomic sites - head/neck, upper extremities, trunk and lower extremities - are assessed for erythema, induration (papules), excoriation and lichenification as seen on the day of the examination. The severity of each sign is assessed using a 4-point scale
Time frame: 5 weeks
Eczema Area and Severity Index (EASI)
Four anatomic sites - head/neck, upper extremities, trunk and lower extremities - are assessed for erythema, induration (papules), excoriation and lichenification as seen on the day of the examination. The severity of each sign is assessed using a 4-point scale
Time frame: Days 7, 14, 21 and 35
Investigator Global Assessment (IGA)
The IGA scale awards a score of 0-4 from clear to severe disease. IGA uses clinical characteristics of erythema, infiltration, population and oozing as scoring guidelines for the overall severity assessment.
Time frame: Days 7, 14, 21 and 35
SCORing Atopic Dermatitis
Six items (erythema, edema/papulation, oozing/crusts, excoriation, lichenification, and dryness) are selected to evaluate the AD severity. The intensity of each item is graded using a 4-point scale.
Time frame: Days 7, 14, 21 and 35
Target Lesion Score
Moderate to severe target lesions will be graded for erythema, induration, excoriation and lichenification using local SCORAD scales.
Time frame: Days 7, 14, 21 and 35
Visual Analogue Scale (VAS)
11 points scale to assess pruritus
Time frame: Days 7, 14, 21 and 35
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Skin Tolerability
Skin tolerability will be self-assessed by the subjects using a questionnaire.
Time frame: Days 7, 14, 21 and 35
Dermatology Life Quality Index
The DLQI is a simple 10-question validated questionnaire which will be completed at each visit.
Time frame: Days 7, 14, 21 and 35
Erythema
Erythema will be assessed with the skin Colorimeter CL 400
Time frame: Days 7, 14, 21 and 35
Transepidermal Water Loss
Measures the effect on skin barrier function.
Time frame: Days 7, 14, 21 and 35
Time to Rescue Medication
Time frame: 5 weeks