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Comparison of Different Concentrations of Carbamide as Moisturizers in Ichthyosis Vulgaris (UreaIchthyosis)

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ClinicalTrials.gov Identifier: NCT02978209
Recruitment Status : Unknown
Verified November 2016 by University of Aarhus.
Recruitment status was:  Enrolling by invitation
First Posted : November 30, 2016
Last Update Posted : November 30, 2016
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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Brief Summary:
A randomized double blinded clinical trial will be conducted comparing the effect of three simple basic moisturizers only different in the concentration of carbamide (urea). Three concentrations of carbamide will be tested, 5, 7.5, and 10 %, respectively. The study will be conducted as a split-body-study and will contain three arms randomized to comparing 5 and 7.5 %, 5 and 10 %, and 7.5 and 10 % carbamide, respectively. 20-30 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 Other: Comparing the effect of moisturizers with 5 and 7.5 % carbamide, respectively Other: Comparing the effect of moisturizers with 5 and 10 % carbamide, respectively Other: Comparing the effect of moisturizers with 7.5 and 10 % carbamide, respectively Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris
Study Start Date : December 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 5 and 7.5 %
20-30 patients with Ichthyosis Vulgaris at age 0-80 years old.
 Other: Comparing the effect of moisturizers with 5 and 7.5 % carbamide, respectively
Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 5 % 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 Name: Carbamide = Urea
Active Comparator: 5 and 10 %
20-30 patients with Ichthyosis Vulgaris at age 0-80 years old.
 Other: Comparing the effect of moisturizers with 5 and 10 % carbamide, respectively
Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 5 % on one half of the body twice a day while applying the same moisturizer with 10 % urea on the other half of the body in the same quantity at the same frequence
Other Name: Carbamide = Urea
Active Comparator: 7.5 and 10 %
20-30 patients with Ichthyosis Vulgaris at age 0-80 years old.
 Other: Comparing the effect of moisturizers with 7.5 and 10 % carbamide, respectively
Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 7.5 % on one half of the body twice a day while applying the same moisturizer with 10 % urea on the other half of the body in the same quantity at the same frequence
Other Name: Carbamide = Urea


Outcome Measures
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Primary Outcome Measures :
  1. Skin dryness [ Time Frame: 2-8 weeks ]
    Transepidermal water loss (`TEWL) (g/m2/h)


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinically diagnosed with Ichthyosis Vulgaris

Exclusion Criteria:

  • All other forms of Ichthyosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02978209


Locations
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Denmark
Department of Dermatology, Aarhus University Hospital
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT02978209     History of Changes
Other Study ID Numbers: UFKOPAUH201601
First Posted: November 30, 2016    Key Record Dates
Last Update Posted: November 30, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
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Ichthyosis
Ichthyosis, Lamellar
Ichthyosis Vulgaris
Skin Abnormalities
Congenital Abnormalities
Infant, Newborn, Diseases
Keratosis
 Skin Diseases
Ichthyosiform Erythroderma, Congenital
Skin Diseases, Genetic
Genetic Diseases, Inborn
Carbamide Peroxide
Anti-Infective Agents, Local
Anti-Infective Agents