Measure of Acceptance of chRonic Visible sKin conditionS

NCT06103903 | Unknown

• 1 other identifier: MARKS
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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).

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Children aged 6-13 years

Children aged 6-13 years with a chronic skin visible disease

Behavioral: Questionnaire

Adolescents aged 14-17 years

Adolescents aged 14-17 years years with a chronic skin visible disease

Behavioral: Questionnaire

Adult patients

Adult patients aged 18 years and more with a chronic skin visible disease

Behavioral: Questionnaire

Parents of children aged 6 years and more

Parents of children aged 6 years and more with a chronic skin visible disease

Behavioral: Questionnaire

Interventions

Questionnaire BEHAVIORAL

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

Adolescents aged 14-17 years; Adult patients; Children aged 6-13 years; Parents of children aged 6 years and more

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with visible chronic dermatological diseases and their family circle

You may qualify if:

• Targeted pathologies:
• Flat angioma
• Primary hypopigmentation and early vitiligo
• Primary hyperpigmentation
• Refractory alopecia areata or congenital alopecia
• 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
• Oral agreement for each person (major/minor) and, where applicable, one of the holders of parental authority (minor)

You may not qualify if:

• Secondary "marks" (post-inflammatory, post-medication, post-traumatic, etc.)
• Major psychiatric disorders

Sponsors & Collaborators

• University Hospital, Tours: lead
• INSERM UMR 1246 SPHERE: collaborator

Study Sites (1)

University Hospital TOURS

Tours, 37044, France

RECRUITING

MeSH Terms

Conditions

Psychological Well-Being; Vitiligo; Port-Wine Stain; Hyperpigmentation; Alopecia Areata

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Hypopigmentation; Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alopecia; Hypotrichosis; Hair Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Annabel MARUANI, MD-PhD

  University Hospital of TOURS

  STUDY DIRECTOR

• Jean-Benoit HARDOUIN, MD-PhD

  INSERM UMR 1246 SPHERE

  STUDY CHAIR

Central Study Contacts

Annabel MARUANI, MD-PhD

CONTACT

+33 (0)247479076; annabel.maruani@univ-tours.fr

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: October 27, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 27, 2023

Record last verified: 2023-10

Locations

FR (1)