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Topical steroid creams as well as moisturizing creams are important parts of the treatment strategy of atopic eczema. This study aims to investigate the tolerance of a new strong steroid cream in comparison to an already marketed reference cream with equal amount of active but with different cream vehicle. The second part of the study will investigate the possible preventative property of a moisturizing cream on skin that has been previously cleared from eczema.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1:1 | Experimental | Part 1 - eczema treatment |
|
| 1:2 | Active Comparator | Part 1 - eczema treatment |
|
| 2:1 | Experimental | Part 2 - maintenance treatment |
|
| 2:2 | No Intervention | Part 2 - maintenance treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| betamethasone valerate | Drug | Topical application according to a fixed schedule for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To study the compatibility of the skin with the new formulation in comparison to the reference medication. | 3 weeks | |
| To study the effect of maintenance therapy with an emollient cream on the possible recurrence of atopic eczema. | Up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| To study cosmetic acceptance of the corticosteroids | 3 weeks | |
| To study the safety of corticosteroid treatment. | 3 weeks | |
| To study the safety of maintenance treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Berit Berne, MD | Hudkliniken, Akademiska sjukhuset, Uppsala | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nacka hudmottagning | Nacka | 13183 | Sweden | |||
| Nacka närsjukhus |
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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 |
|---|---|
| D001624 | Betamethasone Valerate |
| D014508 | Urea |
| ID | Term |
|---|---|
| D001623 | Betamethasone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| betamethasone valerate | Drug | Topical application according to a fixed schedule for three weeks |
|
|
| urea | Drug | Topical application twice daily for up to 6 months |
|
|
| Up to 6 months. |
| Nacka |
| 13183 |
| Sweden |
| Sophiahemmet | Stockholm | 11486 | Sweden |
| Hudkliniken, Danderyds sjukhus | Stockholm | 18288 | Sweden |
| Läkarhuset Vällingby | Vällingby | 16862 | Sweden |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000577 | Amides |
| D009930 | Organic Chemicals |