Back to resultsComparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris (Urea-IV)
Primary Purpose
Ichthyosis Vulgaris
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
7.5 %
Sponsored by
About this trial
This is an interventional treatment trial for Ichthyosis Vulgaris
Eligibility Criteria
Inclusion Criteria:
- Clinically diagnosed with Ichthyosis Vulgaris
Exclusion Criteria:
- All other forms of Ichthyosis
Sites / Locations
- Department of Dermatology, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Only moisturizer, no carbamide
Moisturizer + 7,5 % carbamide
Arm Description
20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half
Outcomes
Primary Outcome Measures
Skin dryness
Transepidermal water loss ('TEWL) (g/m2/h)
Secondary Outcome Measures
Full Information
NCT ID
NCT02978209
First Posted
November 8, 2016
Last Updated
October 29, 2019
Sponsor
University of Aarhus
1. Study Identification
Unique Protocol Identification Number
NCT02978209
Brief Title
Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris
Acronym
Urea-IV
Official Title
Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2020 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ichthyosis Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Only moisturizer, no carbamide
Arm Type
No Intervention
Arm Description
20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
Arm Title
Moisturizer + 7,5 % carbamide
Arm Type
Active Comparator
Arm Description
20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half
Intervention Type
Device
Intervention Name(s)
7.5 %
Other Intervention Name(s)
Carbamide = Urea
Intervention Description
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
Primary Outcome Measure Information:
Title
Skin dryness
Description
Transepidermal water loss ('TEWL) (g/m2/h)
Time Frame
2-8 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinically diagnosed with Ichthyosis Vulgaris
Exclusion Criteria:
All other forms of Ichthyosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uffe Koppelhus, MD, PhD
Organizational Affiliation
Associate professsor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
35663767
Citation
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.
Results Reference
derived
Learn more about this trial
Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris
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