Quality of Life in Middle-aged and Older Patients With Congenital Ichthyosis

NCT ID: NCT05610306

Last Updated: 2025-10-01

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

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-14

Study Completion Date

2023-07-31

Brief Summary

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The goal of this observational study is to learn about the quality of life in patients with congenital ichthyosis.

The main question it aims to answer are:

• What is the impact of ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with inherited ichthyosis ?

Participants will take part in individual interviews in which the investigators will explore if and how ichthyosis impacts their quality of life. Examples of such questions are whether participants experience pain, experience struggles in their personal or professional lives, with sports activities or if participants experience a financial burden.

Detailed Description

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There is limited knowledge on factors affecting the quality of life in patients with ichthyosis, especially in middle-aged and elderly patients. With this study the investigators aim to study the impact of inherited ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with ichthyosis.

Secondary research questions include:

1. What is the impact of ichthyosis on the biological quality of life; by analysing physical complaints, adverse events and drug management in patients with long-term medication use of both topical and systemic treatments, and discussing the sexual health and reproductive challenges?
2. What is the impact of ichthyosis on the psychological quality of life; by examining patients' self-esteem and any clinical symptoms of body dysmorphic disorder, and mental and emotional complaints such as concerns about their future care?
3. What is the impact of ichthyosis on the social quality of life; by analysing interpersonal relationships, social support dynamics, societal costs and awareness, and career opportunities?

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

Conditions

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Congenital Ichthyosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Inherited ichthyosis patients

Interviews

Qualitative interview

Intervention Type OTHER

Qualitative interviews to gain insight into the impact of ichthyosis on the biological, psychological, and social quality of life in adult and elderly patients.

Interventions

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Qualitative interview

Qualitative interviews to gain insight into the impact of ichthyosis on the biological, psychological, and social quality of life in adult and elderly patients.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 30 years of age and older
* Clinical or genetic confirmed variant of congenital ichthyosis

Exclusion Criteria

* \<30 years of age
* ichthyosis vulgaris
* another primary chronic skin condition besides ichthyosis
* patients who are not able to read/speak Dutch
Minimum Eligible Age

30 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 H Gostynski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

MAASTRICHT UMC+

Locations

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Maastricht University Medical Centre +

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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METC 2020-3226A3

Identifier Type: -

Identifier Source: org_study_id

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