Urea-IV: Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT02978209

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Ichthyosis Vulgaris	Device: 7.5 %	N/A

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Nov 1, 2019

Anticipated Primary Completion Date :

Jan 1, 2020

Anticipated Study Completion Date :

Mar 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Only moisturizer, no carbamide 20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
Active Comparator: Moisturizer + 7,5 % carbamide 20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half	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 Names: Carbamide = Urea

Arm

Intervention/Treatment

No Intervention: Only moisturizer, no carbamide

20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half

Active Comparator: Moisturizer + 7,5 % carbamide

20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half

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 Names:

Carbamide = Urea

Outcome Measures

Primary Outcome Measures

Skin dryness [2-8 weeks]
Transepidermal water loss ('TEWL) (g/m2/h)

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinically diagnosed with Ichthyosis Vulgaris

Exclusion Criteria:

All other forms of Ichthyosis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dermatology, Aarhus University Hospital	Aarhus		Denmark	DK-8000

Sponsors and Collaborators

University of Aarhus

Investigators

Principal Investigator: Uffe Koppelhus, MD, PhD, Associate professsor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT02978209

Other Study ID Numbers:

UFKOPAUH201601

First Posted:

Nov 30, 2016

Last Update Posted:

Nov 1, 2019

Last Verified:

Feb 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ichthyosis

Ichthyosis, Lamellar

Ichthyosis Vulgaris

Study Results

No Results Posted as of Nov 1, 2019