NCT06123091

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 8, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

November 8, 2023

Status Verified

October 1, 2023

Enrollment Period

1.1 years

First QC Date

October 18, 2023

Last Update Submit

November 6, 2023

Conditions

Congenital Ichthyosis

Outcome Measures

Primary Outcomes (1)

  • Extracutaneous manifestations in general

    Evaluation of possible extracutaneous manifestations patients with congenital ichthyosis exhibit. This is measured by a questionnaire the investigators have composed. The questions entail patient reported outcomes on their general health and the health issues patients experience due to ichthyosis.

    Day 1

Secondary Outcomes (8)

  • Prevalence of joint complaints measured by the Psoriasis Epidemiology Screening Tool

    Day 1

  • Prevalence of joint complaints measured by the Early Arthritis Recognition Clinic questionnaire

    Day 1

  • Prevalence of joint complaints Early Arthritis for Psoriatic patients questionnaire

    Day 1

  • Prevalence of joint complaints measured by the Clinical Arthritis Rule questionnaire

    Day 1

  • Impact of ichthyosis on quality of life

    Day 1

  • +3 more secondary outcomes

Study Arms (1)

Congenital ichthyosis patients

Questionnaires

Other: Questionnaires with patient reported outcome measures

Interventions

Questionnaires with patient reported outcome measuresOTHER

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

Congenital ichthyosis patients

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 16 years and older, who have a clinically and genetically confirmed congenital ichthyosis

You may qualify if:

  • years and older
  • Clinically and genetically confirmed congenital ichthyosis

You may not qualify if:

  • \<16 years of age
  • Not able to read Dutch
  • Not able to fill in questionnaires online or in print

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre +

Maastricht, 6229HX, Netherlands

RECRUITING

MeSH Terms

Conditions

Ichthyosis Vulgaris

Interventions

Surveys and QuestionnairesPatient Reported Outcome Measures

Condition Hierarchy (Ancestors)

IchthyosisSkin AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSkin Diseases, GeneticGenetic Diseases, InbornKeratosisSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthHealth Care SurveysHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareHealth Services Administration

Study Officials

  • Antoni C Gostynski, MD, PhD

    Maastricht UMC+

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanya Rossel, MD

CONTACT

+31(0)43-3877295vanya.rossel@mumc.nl

Study Design

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

Study Record Dates

First Submitted

October 18, 2023

First Posted

November 8, 2023

Study Start

September 1, 2023

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

November 8, 2023

Record last verified: 2023-10

Locations

NL(1)