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Atopic Dermatitis is a chronic inflammatory skin disease that affect 10 to 15% of children and 2 to 10% of adults. AD is characterised by an itchy skin eruption and may cover large parts of the body. The exact cause is unknown but is thought to be an interplay between genetic and and environmental factors. The objective of this study is to determine whether SRD441 ointment is a safe and effective therapy for mild to moderate Atopic Dermatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle ointment | Placebo Comparator |
| |
| SRD441 Ointment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vehicle ointment | Other | Topical vehicle cream |
| |
| Ointment |
| Measure | Description | Time Frame |
|---|---|---|
| Measure efficacy in treating acute exacerbations | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and local dermal tolerability | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Tansley | Serentis Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Plovdiv | Bulgaria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21039597 | Derived | Foelster Holst R, Reitamo S, Yankova R, Worm M, Kadurina M, Thaci D, Bieber T, Tsankov N, Enk A, Luger T, Duffy M, Tansley R. The novel protease inhibitor SRD441 ointment is not effective in the treatment of adult subjects with atopic dermatitis: results of a randomized, vehicle-controlled study. Allergy. 2010 Dec;65(12):1594-9. doi: 10.1111/j.1398-9995.2010.02417.x. Epub 2010 Sep 7. |
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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 |
|---|---|
| D009824 | Ointments |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Drug |
SRD441 Ointment |
|
| Sofia |
| Bulgaria |
| Helsinki | Finland |
| Berlin | Germany |
| Bonn | Germany |
| Cologne | Germany |
| Frankfurt | Germany |
| Hanover | Germany |
| Heidelberg | Germany |
| Kiel | Germany |
| Munich | Germany |
| Münster | Germany |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |