NCT05833880

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2023

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2023

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

April 2, 2023

Last Update Submit

November 28, 2023

Conditions

Keywords

Atopic DermatitisAtopic EczemaComplementary and Alternative Medicine

Outcome Measures

Primary Outcomes (1)

  • Binary variable: use of complementary and alternative medicine (yes/no)

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

    Baseline (J0)

Secondary Outcomes (5)

  • Percentage of patients using complementary and alternative medicine in relation to the total number of patients included in the study

    Baseline (J0)

  • Forms of complementary and alternative medicine used

    Baseline (J0)

  • Modalities of use of complementary and alternative medicine

    Baseline (J0)

  • Patients' motivations for using complementary and alternative medicine

    Baseline (J0)

  • Sources of information regarding complementary and alternative medicine

    Baseline (J0)

Study Arms (1)

Atopic dermatitis patients

Behavioral: Self-administered questionnaire

Interventions

Self-administered questionnaire regarding complementary and alternative medicine use

Atopic dermatitis patients

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of all ages suffering from atopic dermatitis visiting the dermatology or pediatric allergology department of Nancy University Hospital

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Nancy

Nancy, France

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Skin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, EczematousHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Anne-Claire Bursztejn

    University Hospital of Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Head of Dermatology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

April 2, 2023

First Posted

April 27, 2023

Study Start

May 10, 2023

Primary Completion

August 3, 2023

Study Completion

August 3, 2023

Last Updated

December 1, 2023

Record last verified: 2023-11

Locations