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A randomized double blinded clinical trial will be conducted comparing the effect of two simple basic moisturizers only different in the concentration of carbamide (urea). The concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 % carbamide, respectively. Approximately 20 patients with at least clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will be assessed by clinical examination (score), patients assesment of effect and measurement of transepidermal water loss (TEWL) and other skin parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only moisturizer, no carbamide | No Intervention | 20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half | |
| Moisturizer + 7,5 % carbamide | Active Comparator | 20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 7.5 % | Device | Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 0 % on one half of the body twice a day while applying the same moisturizer with 7.5 % urea on the other half of the body in the same quantity at the same frequence |
| Measure | Description | Time Frame |
|---|---|---|
| Skin dryness | Transepidermal water loss ('TEWL) (g/m2/h) | 2-8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uffe Koppelhus, MD, PhD | Associate professsor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Aarhus University Hospital | Aarhus | DK-8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35663767 | Derived | Dorf ILH, Lunen MS, Koppelhus U. Effect of topical treatment with 7.5% urea in Ichthyosis Vulgaris: A randomized, controlled, double blinded, split body study evaluating the effect of urea cream compared to the vehicle (moisturizing) cream. Skin Health Dis. 2021 Sep 14;1(4):e65. doi: 10.1002/ski2.65. eCollection 2021 Dec. |
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| ID | Term |
|---|---|
| D016112 | Ichthyosis Vulgaris |
| ID | Term |
|---|---|
| D007057 | Ichthyosis |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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|
|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |