Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris

Ichthyosis Vulgaris Clinical Trial

— Urea-IV  

Official title:

Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02978209
• Other study ID #: UFKOPAUH201601
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: February 2019
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: March 31, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinically diagnosed with Ichthyosis Vulgaris

Exclusion Criteria:

• All other forms of Ichthyosis

Related Conditions & MeSH terms

• Ichthyosis
• Ichthyosis Vulgaris
• Ichthyosis, Lamellar

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Dermatology, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin dryness	Transepidermal water loss (`TEWL) (g/m2/h)	2-8 weeks