Exploring Patient Reported Outcomes in Inherited Ichthyosis

November 6, 2023 updated by: Maastricht University Medical Center

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
      • Maastricht, Netherlands, 6229HX
        • Recruiting
        • Maastricht University Medical Centre +
        • Principal Investigator:
          • Antoni Gostynski, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Congenital ichthyosis patients
Questionnaires
Other: Questionnaires with patient reported outcome measures
Questionnaires to gain insight of the prevalence of extracutaneous manifestations and the impact of the disease on the quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extracutaneous manifestations in general
Time Frame: Day 1
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of joint complaints measured by the Psoriasis Epidemiology Screening Tool
Time Frame: Day 1
Prevalence of joint complaints measured by the Psoriasis Epidemiology Screening Tool (PEST). The higher the total score, the more joint complaints patients with congenital ichthyosis experience.
Day 1
Prevalence of joint complaints measured by the Early Arthritis Recognition Clinic questionnaire
Time Frame: Day 1
Prevalence of joint complaints measured by the Early Arthritis Recognition Clinic (EARC) questionnaire. The higher the total score, the more joint complaints patients with congenital ichthyosis experience.
Day 1
Prevalence of joint complaints Early Arthritis for Psoriatic patients questionnaire
Time Frame: Day 1
Prevalence of joint complaints measured by the Early Arthritis for Psoriatic patients (EARP) questionnaire. The higher the total score, the more joint complaints patients with congenital ichthyosis experience.
Day 1
Prevalence of joint complaints measured by the Clinical Arthritis Rule questionnaire
Time Frame: Day 1
Prevalence of joint complaints measured by the Clinical Arthritis Rule (CARE) questionnaire. The higher the total score, the more joint complaints patients with congenital ichthyosis experience.
Day 1
Impact of ichthyosis on quality of life
Time Frame: Day 1
Evaluation of quality of life measured by the Dermatology Life Quality Index (DLQI) questionnaire. Scores range from 0-30, where a higher score indicates that the skin disease has a bigger influence on their quality of life.
Day 1
Impact of ichthyosis on quality of life measured by Skindex-29
Time Frame: Day 1
Evaluation of the quality of life of patients with congenital ichthyosis measured by the Skindex-29 questionnaire. Scores ranging from >25 and >44, where a higher score indicates that the skin disease has a bigger influence on their quality of life.
Day 1
Prevalence of itch complaints
Time Frame: Day 1
Evaluation of possible extracutaneous manifestations patients with congenital ichthyosis exhibit. This is measured by a numeric rating scale (NRS) of itch. The higher the outcome, the more itch patients experience
Day 1
Prevalence of pain complaints
Time Frame: Day 1
Evaluation of possible extracutaneous manifestations patients with congenital ichthyosis exhibit. This is measured by a numeric rating scale (NRS) of pain. The higher the outcome, the more pain the patients experience
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Antoni C Gostynski, MD, PhD, Maastricht UMC+

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 18, 2023

First Submitted That Met QC Criteria

November 6, 2023

First Posted (Actual)

November 8, 2023

Study Record Updates

Last Update Posted (Actual)

November 8, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • METC2023-0122-A-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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