Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris

Not Applicable

• Conditions: Ichthyosis Vulgaris
• Interventions: Device: 7.5 %

• Registration Number: NCT02978209
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-08
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Status Verified: 2019-02
• Last Update Submitted: 2019-10-29
• Study Start: 2019-11-01
• Last Update Posted: 2019-11-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Clinically diagnosed with Ichthyosis Vulgaris

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Exclusion Criteria

• All other forms of Ichthyosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Moisturizer + 7,5 % carbamide	7.5 %	20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half

Primary Outcome Measures

Name	Time	Method
Skin dryness	2-8 weeks	Transepidermal water loss ('TEWL) (g/m2/h)

Trial Locations

Locations (1)

Department of Dermatology, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark