Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris
Urea-IV
Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2016
CompletedFirst Posted
Study publicly available on registry
November 30, 2016
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2020
CompletedNovember 1, 2019
February 1, 2019
2 months
November 8, 2016
October 29, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Skin dryness
Transepidermal water loss ('TEWL) (g/m2/h)
2-8 weeks
Study Arms (2)
Only moisturizer, no carbamide
NO INTERVENTION20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
Moisturizer + 7,5 % carbamide
ACTIVE COMPARATOR20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half
Interventions
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
Eligibility Criteria
You may qualify if:
- Clinically diagnosed with Ichthyosis Vulgaris
You may not qualify if:
- All other forms of Ichthyosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Dermatology, Aarhus University Hospital
Aarhus, DK-8000, Denmark
Related Publications (1)
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.
PMID: 35663767DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Uffe Koppelhus, MD, PhD
Associate professsor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2016
First Posted
November 30, 2016
Study Start
November 1, 2019
Primary Completion
January 1, 2020
Study Completion
March 31, 2020
Last Updated
November 1, 2019
Record last verified: 2019-02