Acceptance of Visible Chronic Dermatological DiseaseMARKSNCT06103903
Measure of Acceptance of chRonic Visible sKin conditionS
An observational study of Acceptance of Visible Chronic Dermatological Disease and Disease Acceptance, run by University Hospital, Tours at 1 site in France.
Trial summary
The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Acceptance of Visible Chronic Dermatological Disease, Disease Acceptance, Psychological Well-Being
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 31 Dec 2025
- 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 6 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients with visible chronic dermatological diseases and their family circle
Who may be able to join
- Targeted pathologies:
- Flat angioma
- Primary hypopigmentation and early vitiligo
- Primary hyperpigmentation
- Refractory alopecia areata or congenital alopecia
- Persons concerned:
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- Children (≥ 6 years old) suffering from one of the aforementioned pathologies
- Adults suffering from one of the above-mentioned pathologies
- Parents of children suffering from one of the aforementioned pathologies
- Parents of young adult patients if they live under the same roof
- Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor)
Who cannot join
- Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.)
- Major psychiatric disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital TOURS
Tours, 37044
Annabel MARUANI, MD-PhD, +33247479076, annabel.maruani@univ-tours.fr
About this study
Official title: Acceptance Des Maladies Chroniques Dermatologiques Visibles : Constitution d'échelles Pour le Patient et Son Cluster Familial
The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).
Read the detailed description
The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).
The investigator will screen the patients and give them a link to complete the questionnaire (according to the age), that includes a pre-scale of acceptation of 50-55 items.
- Conditions
- Acceptance of Visible Chronic Dermatological Disease, Disease Acceptance, Psychological Well-Being, Social Segregation
- Being tested
- Questionnaire
- Keywords
- Chronic dermatological disease, Psychology, Sociology, Disease Acceptance, Vitiligo, port wine stain, hyperpigmentation, alopecia areata
- Medical subject headings
- Psychological Well-Being, Vitiligo, Port-Wine Stain, Hyperpigmentation, Alopecia Areata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire according to age (6-13;14-17); the parents for minors and adults
| Study group | Role | What they receive |
|---|---|---|
| Children aged 6-13 years | Children aged 6-13 years with a chronic skin visible disease Receives: Behavioral: Questionnaire | |
| Adolescents aged 14-17 years | Adolescents aged 14-17 years years with a chronic skin visible disease Receives: Behavioral: Questionnaire | |
| Adult patients | Adult patients aged 18 years and more with a chronic skin visible disease Receives: Behavioral: Questionnaire | |
| Parents of children aged 6 years and more | Parents of children aged 6 years and more with a chronic skin visible disease Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire analysis
Analysis of responses to the 4 questionnaires (scales) evaluating the acceptance of chronic dermatological diseases visible in children, adolescents, adults and parents, respectively.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Jan 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acceptance of Visible Chronic Dermatological DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR 1246 SPHERE
- Responsible party
- Sponsor
- Investigators
- Annabel MARUANI, MD-PhD, Study director, University Hospital of TOURSJean-Benoit HARDOUIN, MD-PhD, Study chair, INSERM UMR 1246 SPHERE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103903
- Sponsor's protocol ID
- MARKS
- Acronym
- MARKS
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 27 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance Des Maladies Chroniques Dermatologiques Visibles : Constitution d'échelles Pour le Patient et Son Cluster Familial
- ClinicalTrials.gov ID
- NCT06103903
- Acronym / sponsor ID
- MARKS / MARKS
- Conditions
- Acceptance of Visible Chronic Dermatological Disease, Disease Acceptance, Psychological Well-Being, Social Segregation
- Keywords
- Chronic dermatological disease, Psychology, Sociology, Disease Acceptance, Vitiligo, port wine stain, hyperpigmentation, alopecia areata
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- INSERM UMR 1246 SPHERE
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Oct 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 objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).
Detailed description
The objective of this protocol is to validate 4 scales for evaluating the acceptance of visible chronic dermatological diseases (port wine stains, alopecia areata, vitiligo, hyperpigmentation...) with a large number of patients (children, adolescents, adults) and their parents (depending on the composition of the family cluster), in a multicentric manner (for territorial representativeness).
The investigator will screen the patients and give them a link to complete the questionnaire (according to the age), that includes a pre-scale of acceptation of 50-55 items.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children aged 6-13 years | – | Behavioral: QuestionnaireChildren aged 6-13 years with a chronic skin visible disease |
| Adolescents aged 14-17 years | – | Behavioral: QuestionnaireAdolescents aged 14-17 years years with a chronic skin visible disease |
| Adult patients | – | Behavioral: QuestionnaireAdult patients aged 18 years and more with a chronic skin visible disease |
| Parents of children aged 6 years and more | – | Behavioral: QuestionnaireParents of children aged 6 years and more with a chronic skin visible disease |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with visible chronic dermatological diseases and their family circle
Key inclusion criteria (11 listed)
- Targeted pathologies:
- Persons concerned:
- Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor)
Key exclusion criteria (2 listed)
- Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.)
- Major psychiatric disorders
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 |
|---|---|---|
| QuestionnaireQuestionnaire according to age (6-13;14-17); the parents for minors and adults | Behavioural | Adolescents aged 14-17 years, Adult patients, Children aged 6-13 years, Parents of children aged 6 years and more |
Primary outcome
Questionnaire analysis
Time frame: Up to 4 weeks
Analysis of responses to the 4 questionnaires (scales) evaluating the acceptance of chronic dermatological diseases visible in children, adolescents, adults and parents, respectively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2023.
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.
Annabel MARUANI, MD-PhD study director
University Hospital of TOURS
Jean-Benoit HARDOUIN, MD-PhD study chair
INSERM UMR 1246 SPHERE
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 Acceptance of Visible Chronic Dermatological Disease and Disease Acceptance, run by University Hospital, Tours at 1 site in France.
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 11 inclusion and 2 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 27 Oct 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 France. 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 Annabel MARUANI, MD-PhD (+33 (0)247479076, annabel.maruani@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire analysis (time frame: Up to 4 weeks). 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 27 Oct 2023.