Congenital IchthyosisNCT05610306
Quality of Life in Middle-aged and Older Patients With Congenital 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 quality of life in patients with congenital ichthyosis. The main question it aims to answer are: What is the impact of ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with inherited ichthyosis ? Participants will… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Congenital Ichthyosis
- What is being tested?
- Qualitative interview
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Nov 2022to 31 Jul 2023
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with congenital ichthyosis
Who may be able to join
- 30 years of age and older
- Clinical or genetic confirmed variant of congenital ichthyosis
Who cannot join
- <30 years of age
- ichthyosis vulgaris
- another primary chronic skin condition besides ichthyosis
- patients who are not able to read/speak Dutch
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre +
Maastricht, 6229HX
About this study
Official title: Quality of Life in Middle-aged and Older Patients With Congenital Ichthyosis: a Qualitative Study With In-depth Interviews
The goal of this observational study is to learn about the quality of life in patients with congenital ichthyosis.
The main question it aims to answer are:
- What is the impact of ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with inherited ichthyosis ?
Participants will take part in individual interviews in which the investigators will explore if and how ichthyosis impacts their quality of life. Examples of such questions are whether participants experience pain, experience struggles in their personal or professional lives, with sports activities or if participants experience a financial burden.
Read the detailed description
There is limited knowledge on factors affecting the quality of life in patients with ichthyosis, especially in middle-aged and elderly patients. With this study the investigators aim to study the impact of inherited ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with ichthyosis.
Secondary research questions include:
- What is the impact of ichthyosis on the biological quality of life; by analysing physical complaints, adverse events and drug management in patients with long-term medication use of both topical and systemic treatments, and discussing the sexual health and reproductive challenges?
- What is the impact of ichthyosis on the psychological quality of life; by examining patients' self-esteem and any clinical symptoms of body dysmorphic disorder, and mental and emotional complaints such as concerns about their future care?
- What is the impact of ichthyosis on the social quality of life; by analysing interpersonal relationships, social support dynamics, societal costs and awareness, and career opportunities?
Furthermore the investigators aim to discover knowledge gaps in current patient management and possible areas of improvement in patient care towards health professionals.
- Conditions
- Congenital Ichthyosis
- Being tested
- Qualitative interview
- Medical subject headings
- Ichthyosis Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative interviewOther
Qualitative interviews to gain insight into the impact of ichthyosis on the biological, psychological, and social quality of life in adult and elderly patients.
| Study group | Role | What they receive |
|---|---|---|
| Inherited ichthyosis patients | Interviews Receives: Other: Qualitative interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life assessment
Qualitative evaluation of quality of life by interviews of patients with inherited ichthyosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start14 Nov 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni H Gostynski, MD, PhD, Principal investigator, Maastricht UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610306
- Sponsor's protocol ID
- METC 2020-3226A3
- Status last verified
- Nov 2024
- First submitted
- 2 Nov 2022
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The interview protocol of the qualitative study. Supplementary Table with patient demographics.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life in Middle-aged and Older Patients With Congenital Ichthyosis: a Qualitative Study With In-depth Interviews
- ClinicalTrials.gov ID
- NCT05610306
- Acronym / sponsor ID
- METC 2020-3226A3
- Conditions
- Congenital Ichthyosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 9 Nov 2022 (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 quality of life in patients with congenital ichthyosis.
The main question it aims to answer are:
- What is the impact of ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with inherited ichthyosis ?
Participants will take part in individual interviews in which the investigators will explore if and how ichthyosis impacts their quality of life. Examples of such questions are whether participants experience pain, experience struggles in their personal or professional lives, with sports activities or if participants experience a financial burden.
Detailed description
There is limited knowledge on factors affecting the quality of life in patients with ichthyosis, especially in middle-aged and elderly patients. With this study the investigators aim to study the impact of inherited ichthyosis on the biological-psychological-social quality of life in adult and elderly patients with ichthyosis.
Secondary research questions include:
- What is the impact of ichthyosis on the biological quality of life; by analysing physical complaints, adverse events and drug management in patients with long-term medication use of both topical and systemic treatments, and discussing the sexual health and reproductive challenges?
- What is the impact of ichthyosis on the psychological quality of life; by examining patients' self-esteem and any clinical symptoms of body dysmorphic disorder, and mental and emotional complaints such as concerns about their future care?
- What is the impact of ichthyosis on the social quality of life; by analysing interpersonal relationships, social support dynamics, societal costs and awareness, and career opportunities?
Furthermore the investigators aim to discover knowledge gaps in current patient management and possible areas of improvement in patient care towards health professionals.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Inherited ichthyosis patients | – | Other: Qualitative interviewInterviews |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with congenital ichthyosis
Key inclusion criteria (2 listed)
- 30 years of age and older
- Clinical or genetic confirmed variant of congenital ichthyosis
Key exclusion criteria (4 listed)
- <30 years of age
- ichthyosis vulgaris
- another primary chronic skin condition besides ichthyosis
- patients who are not able to read/speak Dutch
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 |
|---|---|---|
| Qualitative interviewQualitative interviews to gain insight into the impact of ichthyosis on the biological, psychological, and social quality of life in adult and elderly patients. | Other | Inherited ichthyosis patients |
Primary outcome
Quality of life assessment
Time frame: 1 day
Qualitative evaluation of quality of life by interviews of patients with inherited ichthyosis.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: Yes. The interview protocol of the qualitative study. Supplementary Table with patient demographics.
Related trials for Congenital Ichthyosis
Active, not recruitingPhase 1
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725
Netherton Syndrome
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
RecruitingObservational study
Characterization of Diseases With Salivary Gland Involvement
Healthy Volunteer, Sjogren's Syndrome
RecruitingPhase 2/3
Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
Netherton Syndrome
Not yet recruiting
Patient Study to Evaluate the Safety and Emollient Performance of Doublebase Once in the Treatment of Ichthyosis
Ichthyosis
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 H 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 4 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: finished, as of the sponsor's last update on 1 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life assessment (time frame: 1 day). 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 1 Oct 2025.