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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DS107E and Steroid | Experimental | First 7 days: Steroid taken topically once a day and DS107E taken once a day Next 28 days: DS107E taken topically twice a day |
|
| Vehicle and Steroid | Placebo Comparator | First 7 days: Steroid taken topically once a day and Vehicle taken once a day Next 28 days: Vehicle taken topically twice a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DS107E | Drug |
|
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Days 7, 14, 21 and 35 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DS Biopharma Investigational Site | Lübeck | Germany |
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
|
|
| 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. |
| 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. | 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. | Days 7, 14, 21 and 35 |
| Visual Analogue Scale (VAS) | 11 points scale to assess pruritus | Days 7, 14, 21 and 35 |
| Skin Tolerability | Skin tolerability will be self-assessed by the subjects using a questionnaire. | 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. | Days 7, 14, 21 and 35 |
| Erythema | Erythema will be assessed with the skin Colorimeter CL 400 | Days 7, 14, 21 and 35 |
| Transepidermal Water Loss | Measures the effect on skin barrier function. | Days 7, 14, 21 and 35 |
| Time to Rescue Medication | 5 weeks |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |