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

Quality of Life in Middle-aged and Older Patients With Congenital Ichthyosis: a Qualitative Study With In-depth Interviews

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.

Study Overview

• Status: Completed
• Conditions: Congenital Ichthyosis
• Intervention / Treatment: Other: Qualitative interview

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, 6229HX
    • Maastricht University Medical Centre +

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who are diagnosed with congenital ichthyosis

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Inherited ichthyosis patients; Interviews	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life assessment	Qualitative evaluation of quality of life by interviews of patients with inherited ichthyosis.	1 day

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Investigators: Principal Investigator: Antoni H Gostynski, MD, PhD, Maastricht UMC+

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: November 2, 2022
• First Submitted That Met QC Criteria: November 2, 2022
• First Posted (Actual): November 9, 2022

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Skin Diseases; Congenital Abnormalities; Skin Diseases, Genetic; Skin Abnormalities; Keratosis; Ichthyosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Ichthyosis Vulgaris
• Other Study ID Numbers: METC 2020-3226A3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The interview protocol of the qualitative study. Supplementary Table with patient demographics.
• IPD Sharing Time Frame: From 22-10-2024 onwards, no end date.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No