Atopic DermatitisDACENCT02193230
Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence
An observational study of Atopic Dermatitis, run by Nantes University Hospital at 1 site in France.
Trial summary
Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood. The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy. Read more about this study
- Who is it for?
- Ages 3 to 15 years
- Conditions the study is for
- Atopic Dermatitis
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 14 Oct 2014to 31 Oct 2015
- 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 3 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Multicenter prospective nonrandomized uncontrolled open-label study
Who may be able to join
- Patients experiencing treatment failure despite appropriate treatment. Patients minors aged between 3 and 15 years For children age 7 and non-autonomous children in the application of treatment, the parent at the initial consultation should be the one who treats the child.
- Information from both parents or parental authority and collection of Non-Opposition The patient must have a computer to do its PO-SCORAD between consultations. Patient who used a topical treatment for atopic dermatitis in the week preceding the study.
Who cannot join
- Patient refusal to participate in the clinical study. Adults and children over 15 years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence.
Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.
The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy.
Read more
Studies have shown that this treatment failure is caused by the complexity of the treatment, the time required for its implementation, the cost of treatment, the dosage of the products, fear of side effects or misunderstanding about the chronicity of these diseases inflammatory conditions of the skin.
This study aims to evaluate the consideration of patient preference in the choice of excipient used for the topical treatment of eczema.
Read the detailed description
Day 0 :
- Inclusion, collecting non-opposition
- Presentation of the samples: 4 products presented in the same packaging (pump bottle 200 ml) and ranked in order of their fat content:
- Cold Cream: 88%
- Modified Cerat Galen (national formulary): 66%
- Cold Cream Fluid: 32%
- Ointment: 21% The 4 products are all equally effective and suited in the treatment of atopic dermatitis.
The patient choose the cream it will apply from 4 presented. A total of two bottles will be given to the patient. A bottle containing only the emollient applied to dry areas and another bottle in which 30% will be added Diprosone (topical steroid) to be applied on areas of eczema).
- Remitting the questionnaires
- Severity scoring of atopic dermatitis (SCORAD)
Day 30:
- Remitting the questionnaires
- Treatments delivery for 2 months
- SCORAD / PO SCORAD
- Treatment weighing
Day 90:
- SCORAD / PO-SCORAD
- Treatments weighing
- Remitting the final questionnaire
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Feasibility, Adherence to treatment
- Medical subject headings
- Dermatitis, Atopic, Treatment Adherence and Compliance
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.
Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.
The primary outcome is evaluated through a questionnaire given to the patient/parent at day 0 day 30 day 90.
Measured: 90 days
Secondary outcomes (4)
Evaluate the impact of this procedure in patient adherence to treatment (trough weighing treatments at day 30 and day 90)
Measured: 90 days
Evaluate the impact of this procedure on the evolution of the disease
Evaluate the impact of this procedure on the evolution of the disease (trough SCORAD and PO-SCORAD at day 0, day 30, day 90)
Measured: 90 days
Assess the feasibility point of view of the prescribing physician
- Assess the feasibility point of view of the prescribing physician (through questionnaires at day 0 day 30 day 90)
Measured: 90 days
Measuring the characteristics of a specified product and those of a product chosen by the patient
- Measuring the characteristics of a specified product and those of a product chosen by the patient (through questionnaires at day 0, day 30, day 90)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start14 Oct 2014
- Primary completion30 Sep 2015
- Study completion31 Oct 2015
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 Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François Stalder, PU-PH, Study director, Nantes University HospitalJean-Marc Chavigny, PH, Principal investigator, Centre Pasteur Dermatologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193230
- Sponsor's protocol ID
- RC14_0073
- Acronym
- DACE
- Status last verified
- Sep 2021
- First submitted
- 15 Jul 2014
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Into Account the Patient/Parent Preference in the Galenic Choice in Atopic Dermatitis. Feasibility and Impact on Treatment Adherence.
- ClinicalTrials.gov ID
- NCT02193230
- Acronym / sponsor ID
- DACE / RC14_0073
- Conditions
- Atopic Dermatitis
- Keywords
- Atopic dermatitis, Feasibility, Adherence to treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 30 Sep 2015 (actual)
- Study completion
- 31 Oct 2015 (actual)
- First posted
- 17 Jul 2014 (estimated)
- 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.
Atopic dermatitis is a chronic inflammatory skin disease often occurring in childhood.
The treatment consists in making daily local treatment with topical steroid on inflammatory lesions and emollient on the whole body. However, approximately 70% of patients do not adhere to therapy.
Studies have shown that this treatment failure is caused by the complexity of the treatment, the time required for its implementation, the cost of treatment, the dosage of the products, fear of side effects or misunderstanding about the chronicity of these diseases inflammatory conditions of the skin.
This study aims to evaluate the consideration of patient preference in the choice of excipient used for the topical treatment of eczema.
Detailed description
Day 0 :
- Inclusion, collecting non-opposition
- Presentation of the samples: 4 products presented in the same packaging (pump bottle 200 ml) and ranked in order of their fat content:
- Cold Cream: 88%
- Modified Cerat Galen (national formulary): 66%
- Cold Cream Fluid: 32%
- Ointment: 21% The 4 products are all equally effective and suited in the treatment of atopic dermatitis.
The patient choose the cream it will apply from 4 presented. A total of two bottles will be given to the patient. A bottle containing only the emollient applied to dry areas and another bottle in which 30% will be added Diprosone (topical steroid) to be applied on areas of eczema).
- Remitting the questionnaires
- Severity scoring of atopic dermatitis (SCORAD)
Day 30:
- Remitting the questionnaires
- Treatments delivery for 2 months
- SCORAD / PO SCORAD
- Treatment weighing
Day 90:
- SCORAD / PO-SCORAD
- Treatments weighing
- Remitting the final questionnaire
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Multicenter prospective nonrandomized uncontrolled open-label study
Key inclusion criteria (2 listed)
- Patients experiencing treatment failure despite appropriate treatment. Patients minors aged between 3 and 15 years For children age 7 and non-autonomous children in the application of treatment, the parent at the initial consultation should be the one who treats the child.
- Information from both parents or parental authority and collection of Non-Opposition The patient must have a computer to do its PO-SCORAD between consultations. Patient who used a topical treatment for atopic dermatitis in the week preceding the study.
Key exclusion criteria (1 listed)
- Patient refusal to participate in the clinical study. Adults and children over 15 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis.
Time frame: 90 days
Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis. The primary outcome is evaluated through a questionnaire given to the patient/parent at day 0 day 30 day 90.
4 secondary outcomes
Evaluate the impact of this procedure in patient adherence to treatment (trough weighing treatments at day 30 and day 90)
Time frame: 90 days
Evaluate the impact of this procedure on the evolution of the disease
Time frame: 90 days
Assess the feasibility point of view of the prescribing physician
Time frame: 90 days
Measuring the characteristics of a specified product and those of a product chosen by the patient
Time frame: 90 days
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 16 Sep 2021.
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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.
Jean-François Stalder, PU-PH study director
Nantes University Hospital
Jean-Marc Chavigny, PH principal investigator
Centre Pasteur Dermatologie
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 Nantes University Hospital 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 2 inclusion and 1 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 16 Sep 2021. 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?
Assess the feasibility of giving the choice to the patient/parent of different galenic in atopic dermatitis. (time frame: 90 days). 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 16 Sep 2021.