Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004621-24 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to confirm that emollients play a major role in the maintenance therapy after clearing of inflammatory lesions and can reduce occurrence of flares in children with atopic dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 2 | Other | Active control arm, Locatop@, Locapred@ |
|
| Group 3 | Other | Absence of emollient treatment, Locatop@, Locapred@ |
|
| Group 1 | Experimental | glycerol, paraffin (liquid and white soft), Locatop@ , Locapred@ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glycerol, paraffin (liquid and white soft) | Drug | 1 application in the morning and in the evening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with at least one flare over the treatment period | A flare is defined as following: measurable increased extend or intensity of lesions in less than 2 weeks under continued treatment corresponding to a significant increase in medical score (> 25%) or to the introduction of a new line of therapy(topical corticosteroid). | 12 weeks of treatment. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tallinn | Estonia | |||||
Not provided
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D003872 | Dermatitis |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005990 | Glycerol |
| D010232 | Paraffin |
| D005440 | Fluid Therapy |
| D003898 | Desonide |
| ID | Term |
|---|---|
| D000073999 | Triose Sugar Alcohols |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atopiclair® | Device | 1 application in the morning, in the afternoon and in the evening |
|
| Locatop@ | Drug | During the Run-In period: 1 application in the morning and in the evening during a maximum of 21 days |
|
| Locapred@ | Drug | During the 3 months study treatment: 1 application in the evening in case of flare " |
|
| Tartu |
| Estonia |
| Bordeaux | France |
| Poitiers | France |
| Vilnius | Lithuania |
| Lodz | Poland |
| Pruszków | Poland |
| Płock | Poland |
| Warsaw | Poland |
| Brasov | Romania |
| Bucharest | Romania |
| Craiova | Romania |
| Iași | Romania |
| Sibiu | Romania |
| Targu Mureş | Romania |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002241 |
| Carbohydrates |
| D006838 | Hydrocarbons |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |