Exploring Patient Reported Outcomes in Inherited Ichthyosis

Congenital Ichthyosis Clinical Trial

Official title:

Exploring Patient Reported Outcomes in Inherited Ichthyosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06123091
• Other study ID #: METC2023-0122-A-1
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: October 2023
• Source: Maastricht University Medical Center
• Contact: Vanya Rossel, MD
• Phone: +31(0)43-3877295
• Email: vanya.rossel[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congenital Ichthyosis
• Ichthyosis
• Ichthyosis, Lamellar

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre +	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of joint complaints measured by the Psoriasis Epidemiology Screening Tool	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
Secondary	Prevalence of joint complaints measured by the Early Arthritis Recognition Clinic questionnaire	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
Secondary	Prevalence of joint complaints Early Arthritis for Psoriatic patients questionnaire	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
Secondary	Prevalence of joint complaints measured by the Clinical Arthritis Rule questionnaire	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
Secondary	Impact of ichthyosis on quality of life	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
Secondary	Impact of ichthyosis on quality of life measured by Skindex-29	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
Secondary	Prevalence of itch complaints	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
Secondary	Prevalence of pain complaints	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