Clinical trial NCT06123091: Exploring Patient Reported Outcomes in Inherited Ichthyosis
Official title: Exploring Patient Reported Outcomes in Inherited Ichthyosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Ichthyosis
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2023-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 16 years and older, who have a clinically and genetically confirmed congenital ichthyosis

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Extracutaneous manifestations in general
timeFrame: Day 1
Secondary outcomes:
measure: Prevalence of joint complaints measured by the Psoriasis Epidemiology Screening Tool
timeFrame: Day 1
measure: Prevalence of joint complaints measured by the Early Arthritis Recognition Clinic questionnaire
timeFrame: Day 1
measure: Prevalence of joint complaints Early Arthritis for Psoriatic patients questionnaire
timeFrame: Day 1
measure: Prevalence of joint complaints measured by the Clinical Arthritis Rule questionnaire
timeFrame: Day 1
measure: Impact of ichthyosis on quality of life
timeFrame: Day 1
measure: Impact of ichthyosis on quality of life measured by Skindex-29
timeFrame: Day 1
measure: Prevalence of itch complaints
timeFrame: Day 1
measure: Prevalence of pain complaints
timeFrame: Day 1
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre +
Study officials:
affiliation: Maastricht UMC+
name: Antoni C Gostynski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: