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

NCT05610306 | Completed

• 1 other identifier: METC 2020-3226A3
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Congenital Ichthyosis

Outcome Measures

Primary Outcomes (1)

• Quality of life assessment

  Qualitative evaluation of quality of life by interviews of patients with inherited ichthyosis.

  1 day

Study Arms (1)

Inherited ichthyosis patients

Interviews

Other: Qualitative interview

Interventions

Qualitative interview 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.

Inherited ichthyosis patients

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with congenital ichthyosis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre +

Maastricht, 6229HX, Netherlands

Location

MeSH Terms

Conditions

Ichthyosis Vulgaris

Condition Hierarchy (Ancestors)

Ichthyosis; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Antoni H Gostynski, MD, PhD

  MAASTRICHT UMC+

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 9, 2022
• Study Start: November 14, 2022
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: October 1, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: From 22-10-2024 onwards, no end date.
• Access Criteria: Everyone who accesses the ClinicalTrials.gov website will be able to view the individual participant data (IPD) and supporting information associated with the study.

Locations

NL (1)