Congenital IchthyosisNCT06123091
Exploring Patient Reported Outcomes in Inherited Ichthyosis
An observational study of Congenital Ichthyosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Congenital Ichthyosis
- What is being tested?
- Questionnaires with patient reported outcome measures
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients 16 years and older, who have a clinically and genetically confirmed congenital ichthyosis
Who may be able to join
- 16 years and older
- Clinically and genetically confirmed congenital ichthyosis
Who cannot join
- <16 years of age
- Not able to read Dutch
- Not able to fill in questionnaires online or in print
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Maastricht University Medical Centre +
Maastricht, 6229HX
Vanya Rossel, MD, +31(0)43- 387 7295, genodermatose@mumc.nl
Antoni Gostynski, MD, PhD
About this study
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.
Read the 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.
- Conditions
- Congenital Ichthyosis
- Being tested
- Questionnaires with patient reported outcome measures
- Medical subject headings
- Ichthyosis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Congenital ichthyosis patients | Questionnaires Receives: Other: Questionnaires with patient reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (8)
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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.
Measured: Day 1
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
Measured: Day 1
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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital IchthyosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni C Gostynski, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123091
- Sponsor's protocol ID
- METC2023-0122-A-1
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Patient Reported Outcomes in Inherited Ichthyosis
- ClinicalTrials.gov ID
- NCT06123091
- Acronym / sponsor ID
- METC2023-0122-A-1
- Conditions
- Congenital Ichthyosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 8 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Congenital ichthyosis patients | – | Other: Questionnaires with patient reported outcome measuresQuestionnaires |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients 16 years and older, who have a clinically and genetically confirmed congenital ichthyosis
Key inclusion criteria (2 listed)
- 16 years and older
- Clinically and genetically confirmed congenital ichthyosis
Key exclusion criteria (3 listed)
- <16 years of age
- Not able to read Dutch
- Not able to fill in questionnaires online or in print
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaires with patient reported outcome measuresQuestionnaires to gain insight of the prevalence of extracutaneous manifestations and the impact of the disease on the quality of life. | Other | Congenital ichthyosis patients |
Primary outcome
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.
8 secondary outcomes
Prevalence of joint complaints measured by the Psoriasis Epidemiology Screening Tool
Time frame: Day 1
Prevalence of joint complaints measured by the Early Arthritis Recognition Clinic questionnaire
Time frame: Day 1
Prevalence of joint complaints Early Arthritis for Psoriatic patients questionnaire
Time frame: Day 1
Prevalence of joint complaints measured by the Clinical Arthritis Rule questionnaire
Time frame: Day 1
Impact of ichthyosis on quality of life
Time frame: Day 1
Impact of ichthyosis on quality of life measured by Skindex-29
Time frame: Day 1
Prevalence of itch complaints
Time frame: Day 1
Prevalence of pain complaints
Time frame: Day 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoni C Gostynski, MD, PhD principal investigator
Maastricht UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Ichthyosis, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanya Rossel, MD (+31(0)43-3877295, vanya.rossel@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extracutaneous manifestations in general (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2023.