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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06103903
Other study ID # MARKS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date December 31, 2025

Study information

Verified date October 2023
Source University Hospital, Tours
Contact Annabel MARUANI, MD-PhD
Phone +33 (0)247479076
Email annabel.maruani@univ-tours.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 family cluster), in a multicentric manner (for territorial representativeness).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 250
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers
Gender All
Age group 6 Years and older
Eligibility Inclusion Criteria: 1. Targeted pathologies: - Flat angioma - Primary hypopigmentation and early vitiligo - Primary hyperpigmentation - Refractory alopecia areata or congenital alopecia 2. Persons concerned: - 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 3. Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor) Exclusion Criteria: 1. Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.) 2. Major psychiatric disorders

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Questionnaire
Questionnaire according to age (6-13;14-17); the parents for minors and adults

Locations

Country Name City State
France University Hospital TOURS Tours

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Tours INSERM UMR 1246 SPHERE

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Up to 4 weeks
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