Exploring Patient Reported Outcomes in Inherited Ichthyosis

NCT ID: NCT06123091

Last Updated: 2023-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-12-01

Brief Summary

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The goal of this observational study is to learn about the presence of extracutaneous manifestations in patients with congenital ichthyosis.

The main question it aims to answer is:

\- Do patients with congenital ichthyosis experience extracutaneous manifestations?

Participants will fill in questionnaires in which the investigators will explore whether patients experience extracutaneous manifestations, and if so what these manifestations entail. Examples of such questions are whether patients experience (joint) pain or whether they experience hindrance due to their complaints.

Detailed Description

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There is only limited knowledge about extracutaneous manifestations in patients with congenital ichthyosis. With this study, the investigators aim to identify extracutaneous manifestations with questionaires based on patient reported outcomes.

Secondary research questions include:

* What is the prevalence of joint complaints in patients with congenital ichthyosis
* What is the influence of ichthyosis on the quality of life patients experience

Furthermore, the investigators aim to discover knowledge gaps in current patient management and possible areas of improvement in patient care towards healthcare professionals.

Conditions

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Congenital Ichthyosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Congenital ichthyosis patients

Questionnaires

Questionnaires with patient reported outcome measures

Intervention Type OTHER

Questionnaires to gain insight of the prevalence of extracutaneous manifestations and the impact of the disease on the quality of life.

Interventions

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Questionnaires with patient reported outcome measures

Questionnaires to gain insight of the prevalence of extracutaneous manifestations and the impact of the disease on the quality of life.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 16 years and older
* Clinically and genetically confirmed congenital ichthyosis

Exclusion Criteria

* \<16 years of age
* Not able to read Dutch
* Not able to fill in questionnaires online or in print
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoni C Gostynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Maastricht UMC+

Locations

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Maastricht University Medical Centre +

Maastricht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Vanya Rossel, MD

Role: CONTACT

+31(0)43-3877295

Facility Contacts

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Vanya Rossel, MD

Role: primary

+31(0)43- 387 7295

Other Identifiers

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METC2023-0122-A-1

Identifier Type: -

Identifier Source: org_study_id

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