Atopic Dermatitis
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGDS107E
DRUGVehicle
Sponsors
DS Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Female and male volunteers aged 18-65 who are willing to give written informed consent. * Diagnosis of atopic dermatitis (\> 6 months) according to the Hanifin and Raika Criteria; * Presence of at least 2 moderate to severe (target lesion score\</=8) inflammatory lesions of comparable severity, erythema \>/= 2 * Patients with moderate to severe atopic dermatitis (IGA=3-4) * A body surface area score of less than 20%
Exclusion criteria
* Clinically significant impairment of renal or hepatic function. * Other skin conditions that might interfere with atopic dermatitis diagnosis and/or evaluation (such as psoriasis or current viral, bacterial and fungal skin infections). * History of intolerance to any ingredient in DS107E DGLA cream or Vehicle or intolerance to any ingredient in Ecural®(Mometasone furoate 0.1%). Of note, any intolerance to PHB ester (benzoate, parabens) or soy or it's cross-allergen peanut, as these are ingredients of DS107E. * Use of biologics 3 months prior to start of treatment/ Day 0 visit (baseline), or 5 half-lives (whichever is longer). * Use of systemic treatments (other than biologics) that could affect atopic dermatitis less than 4 weeks prior to baseline visit (Day 0), e.g. retinoids, calcineurin inhibitors, methotrexate, cyclosporine, hydroxycarbamide (hydroxyurea), azathioprine and oral/injectable corticosteroids; Intranasal corticosteroids and inhaled corticosteroids for stable medical conditions are allowed. * Treatment with any experimental drug within 30 days prior to Day 0 visit (baseline), or 5 half lives (whichever is longer). * Excessive sun exposure, use of tanning booths or other ultraviolet (UV) light sources 4 weeks prior to Day 0 visit (baseline) and/or is planning a trip to sunny climate or to use tanning booths or other UV sources between screening and follow-up visits. * Use of any topical medicated treatment for atopic dermatitis 2 weeks prior to start of treatment/Day 0 visit (baseline), including but not limited to, topical corticosteroids, calcineurin inhibitors, tars, bleach, antimicrobials and bleach baths. * Use of topical products containing ceramides 2 weeks prior to Day 0. Topical products that do not contain ceramides are allowed. * Use of anti-histamines for atopic dermatitis within 2 weeks of baseline. * Medical history of chronic infectious disease (e.g., hepatitis B, hepatitis C or infection with human immunodeficiency virus). * History of clinically significant drug or alcohol abuse in the last year prior to Day 0 (baseline).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eczema Area and Severity Index (EASI) | 5 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator Global Assessment (IGA) | Days 7, 14, 21 and 35 | 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. |
| SCORing Atopic Dermatitis | Days 7, 14, 21 and 35 | 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. |
| Target Lesion Score | Days 7, 14, 21 and 35 | Moderate to severe target lesions will be graded for erythema, induration, excoriation and lichenification using local SCORAD scales. |
| Visual Analogue Scale (VAS) | Days 7, 14, 21 and 35 | 11 points scale to assess pruritus |
| Eczema Area and Severity Index (EASI) | Days 7, 14, 21 and 35 | 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 |
| Dermatology Life Quality Index | Days 7, 14, 21 and 35 | The DLQI is a simple 10-question validated questionnaire which will be completed at each visit. |
| Erythema | Days 7, 14, 21 and 35 | Erythema will be assessed with the skin Colorimeter CL 400 |
| Transepidermal Water Loss | Days 7, 14, 21 and 35 | Measures the effect on skin barrier function. |
| Time to Rescue Medication | 5 weeks | — |
| Skin Tolerability | Days 7, 14, 21 and 35 | Skin tolerability will be self-assessed by the subjects using a questionnaire. |
Countries
Germany
Outcome results
None listed