Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris (Urea-IV)
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ClinicalTrials.gov Identifier: NCT02978209 |
Recruitment Status : Unknown
Verified February 2019 by University of Aarhus.
Recruitment status was: Enrolling by invitation
First Posted : November 30, 2016
Last Update Posted : November 1, 2019
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Condition or disease | Intervention/treatment | Phase |
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Ichthyosis Vulgaris | Device: 7.5 % | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris |
Estimated Study Start Date : | November 1, 2019 |
Estimated Primary Completion Date : | January 1, 2020 |
Estimated Study Completion Date : | March 31, 2020 |

Arm | Intervention/treatment |
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No Intervention: Only moisturizer, no carbamide
20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
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Active Comparator: Moisturizer + 7,5 % carbamide
20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half
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Device: 7.5 %
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
Other Name: Carbamide = Urea |
- Skin dryness [ Time Frame: 2-8 weeks ]Transepidermal water loss ('TEWL) (g/m2/h)

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Clinically diagnosed with Ichthyosis Vulgaris
Exclusion Criteria:
- All other forms of Ichthyosis

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978209
Denmark | |
Department of Dermatology, Aarhus University Hospital | |
Aarhus, Denmark, DK-8000 |
Principal Investigator: | Uffe Koppelhus, MD, PhD | Associate professsor |
Responsible Party: | University of Aarhus |
ClinicalTrials.gov Identifier: | NCT02978209 |
Other Study ID Numbers: |
UFKOPAUH201601 |
First Posted: | November 30, 2016 Key Record Dates |
Last Update Posted: | November 1, 2019 |
Last Verified: | February 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ichthyosis Ichthyosis, Lamellar Ichthyosis Vulgaris Skin Abnormalities Congenital Abnormalities Infant, Newborn, Diseases |
Keratosis Skin Diseases Ichthyosiform Erythroderma, Congenital Skin Diseases, Genetic Genetic Diseases, Inborn |