Use of Complementary and Alternative Medicine in Children and Adults With Atopic Dermatitis

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05833880
Collaborator
(none)
80
1
6
13.2

Study Details

Study Description

Brief Summary

Complementary and alternative medicine are increasingly used all around the world and more specifically in chronic diseases such as atopic dermatitis. Sociodemographic and disease determinants associated with their use remain unclear. Moreover, most of studies involved children and little data are available for adults.

The main objective of this study is to identify factors associated with complementary and alternative medicine use in children and adults suffering from atopic dermatitis. The secondary objectives are to determine the prevalence of complementary and alternative medicine use, the main forms used and their modalities of use, patients' motivations for using these therapies and sources of information.

Patients of all ages consulting for their atopic dermatitis at the dermatology or pediatric allergology department of Nancy University Hospital over a 6 months period will be asked to fill out a questionnaire about their pathology and their use of complementary and alternative medicine. This questionnaire will be collected before they leave the hospital.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self-administered questionnaire

Study Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Use of Complementary and Alternative Medicine in Children and Adults With Atopic Dermatitis: a Single-center Prospective Observational Study
Anticipated Study Start Date :
May 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Atopic dermatitis patients

Behavioral: Self-administered questionnaire
Self-administered questionnaire regarding complementary and alternative medicine use

Outcome Measures

Primary Outcome Measures

  1. Binary variable: use of complementary and alternative medicine (yes/no) [Baseline (J0)]

    Binary variable: use of complementary and alternative medicine (yes/no), variable collected by questionnaire, as reported by the patient (or the patient's parents)

Secondary Outcome Measures

  1. Percentage of patients using complementary and alternative medicine in relation to the total number of patients included in the study [Baseline (J0)]

    Percentage of patients using complementary and alternative medicine in relation to the total number of patients included in the study, variable collected by questionnaire according to the patient's declaration (use or not use of complementary and alternative medicine) and then calculated

  2. Forms of complementary and alternative medicine used [Baseline (J0)]

    Forms of complementary and alternative medicine used, variable collected by questionnaire, as reported by the patient (or the patient's parents)

  3. Modalities of use of complementary and alternative medicine [Baseline (J0)]

    Modalities of use of complementary and alternative medicine, variable collected by questionnaire, as reported by the patient (or the patient's parents)

  4. Patients' motivations for using complementary and alternative medicine [Baseline (J0)]

    Patients' motivations for using complementary and alternative medicine, variable collected by questionnaire, as reported by the patient (or the patient's parents)

  5. Sources of information regarding complementary and alternative medicine [Baseline (J0)]

    Sources of information regarding complementary and alternative medicine, variable collected by questionnaire, as reported by the patient (or the patient's parents)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Inclusion Criteria:
  • All patients, adults or children, without age limit;

  • Patients visiting the dermatology or pediatric allergology department of Nancy University Hospital;

  • Patients with atopic dermatitis confirmed on clinical examination by the physician;

  • Patients with a history of atopic dermatitis or newly diagnosed patients;

  • Patient affiliated to a social security plan or beneficiary of such a plan;

  • Patients who understand French and are able to complete a self-administered questionnaire or have the option of assistance in completing it.

Exclusion Criteria:
  • Patient with at least one other dermatological pathology or non-atopic eczema (contact eczema, ...);

  • Patient without a confirmed diagnosis of atopic dermatitis by a physician;

  • Patient who has already completed the questionnaire during a previous consultation;

  • Pregnant and breastfeeding women;

  • Refusal of the patient or at least one of the parents for children;

  • Patient placed under court protection, guardianship or curatorship;

  • Patient deprived of liberty by a judicial or administrative decision.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Nancy Nancy France

Sponsors and Collaborators

  • Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Anne-Claire Bursztejn, University Hospital of Nancy, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anne Claire BURSZTEJN, Director, Head of Dermatology, Principal Investigator, Clinical Professor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT05833880
Other Study ID Numbers:
  • 2023-A00605-40
First Posted:
Apr 27, 2023
Last Update Posted:
May 3, 2023
Last Verified:
Apr 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Anne Claire BURSZTEJN, Director, Head of Dermatology, Principal Investigator, Clinical Professor, Central Hospital, Nancy, France
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 3, 2023