Atopic DermatitisNCT05833880
Use of Complementary and Alternative Medicine in Children and Adults With Atopic Dermatitis
An observational study of Atopic Dermatitis, run by Central Hospital, Nancy, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Self-administered questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2023to 3 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients of all ages suffering from atopic dermatitis visiting the dermatology or pediatric allergology department of Nancy University Hospital
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Complementary and Alternative Medicine in Children and Adults With Atopic Dermatitis: a Single-center Prospective Observational Study
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.
- Conditions
- Atopic Dermatitis
- Being tested
- Self-administered questionnaire
- Keywords
- Atopic Dermatitis, Atopic Eczema, Complementary and Alternative Medicine
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered questionnaireBehavioural
Self-administered questionnaire regarding complementary and alternative medicine use
| Study group | Role | What they receive |
|---|---|---|
| Atopic dermatitis patients | Not described Receives: Behavioral: Self-administered questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
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
Measured: Baseline (J0)
Forms of complementary and alternative medicine used
Forms of complementary and alternative medicine used, variable collected by questionnaire, as reported by the patient (or the patient's parents)
Measured: Baseline (J0)
Modalities of use of complementary and alternative medicine
Modalities of use of complementary and alternative medicine, variable collected by questionnaire, as reported by the patient (or the patient's parents)
Measured: Baseline (J0)
Patients' motivations for using complementary and alternative medicine
Patients' motivations for using complementary and alternative medicine, variable collected by questionnaire, as reported by the patient (or the patient's parents)
Measured: Baseline (J0)
Sources of information regarding complementary and alternative medicine
Sources of information regarding complementary and alternative medicine, variable collected by questionnaire, as reported by the patient (or the patient's parents)
Measured: Baseline (J0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start10 May 2023
- Primary completion3 Aug 2023
- Study completion3 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Claire BURSZTEJN, Central Hospital, Nancy, France
- Investigators
- Anne-Claire Bursztejn, Principal investigator, University Hospital of Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833880
- Sponsor's protocol ID
- 2023-A00605-40
- Status last verified
- Nov 2023
- First submitted
- 2 Apr 2023
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Complementary and Alternative Medicine in Children and Adults With Atopic Dermatitis: a Single-center Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05833880
- Acronym / sponsor ID
- 2023-A00605-40
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic Dermatitis, Atopic Eczema, Complementary and Alternative Medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 3 Aug 2023 (actual)
- Study completion
- 3 Aug 2023 (actual)
- First posted
- 27 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Atopic dermatitis patients | – | Behavioral: Self-administered questionnaire |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of all ages suffering from atopic dermatitis visiting the dermatology or pediatric allergology department of Nancy University Hospital
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered questionnaireSelf-administered questionnaire regarding complementary and alternative medicine use | Behavioural | Atopic dermatitis patients |
Primary outcome
Binary variable: use of complementary and alternative medicine (yes/no)
Time frame: 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)
5 secondary outcomes
Percentage of patients using complementary and alternative medicine in relation to the total number of patients included in the study
Time frame: Baseline (J0)
Forms of complementary and alternative medicine used
Time frame: Baseline (J0)
Modalities of use of complementary and alternative medicine
Time frame: Baseline (J0)
Patients' motivations for using complementary and alternative medicine
Time frame: Baseline (J0)
Sources of information regarding complementary and alternative medicine
Time frame: Baseline (J0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Claire Bursztejn principal investigator
University Hospital of Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atopic Dermatitis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binary variable: use of complementary and alternative medicine (yes/no) (time frame: Baseline (J0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2023.