Measure of Acceptance of chRonic Visible sKin conditionS (MARKS)

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).

Study Overview

• Status: Recruiting
• Conditions: Psychological Well-Being; Acceptance of Visible Chronic Dermatological Disease; Disease Acceptance; Social Segregation
• Intervention / Treatment: Behavioral: Questionnaire

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 Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Annabel MARUANI, MD-PhD; Phone Number: +33 (0)247479076; Email: annabel.maruani@univ-tours.fr

Study Locations

• France
  • Tours, France, 37044
    • Recruiting
    • university hospital Tours
    • Contact: Annabel MARUANI, MD-PhD; Phone Number: +33247479076; Email: annabel.maruani@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with visible chronic dermatological diseases and their family circle

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children aged 6-13 years; Children aged 6-13 years with a chronic skin visible disease	Behavioral: Questionnaire; Questionnaire according to age (6-13;14-17); the parents for minors and adults
Adolescents aged 14-17 years; Adolescents aged 14-17 years years with a chronic skin visible disease	Behavioral: Questionnaire; Questionnaire according to age (6-13;14-17); the parents for minors and adults
Adult patients; Adult patients aged 18 years and more with a chronic skin visible disease	Behavioral: Questionnaire; Questionnaire according to age (6-13;14-17); the parents for minors and adults
Parents of children aged 6 years and more; Parents of children aged 6 years and more with a chronic skin visible disease	Behavioral: Questionnaire; Questionnaire according to age (6-13;14-17); the parents for minors and adults

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Collaborators: INSERM UMR 1246 SPHERE
• Investigators: Study Director: Annabel MARUANI, MD-PhD, University Hospital of TOURS; Study Chair: Jean-Benoit HARDOUIN, MD-PhD, INSERM UMR 1246 SPHERE

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 18, 2023
• First Submitted That Met QC Criteria: October 24, 2023
• First Posted (Actual): October 27, 2023

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 24, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: hyperpigmentation; Vitiligo; Psychology; alopecia areata; Sociology; port wine stain; Chronic dermatological disease; Disease Acceptance
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: MARKS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No