Chronic Hand EczemaCARINGNCT05545215
Prospective Real-World Clinical Investigation on Dexyane Med® in Adults With Chronic Hand Eczema
An observational study of Chronic Hand Eczema, run by Pierre Fabre Medicament.
Trial summary
Prospective, descriptive, multicenter, real-world, international clinical investigation. Data collection is based on current clinical practice over a 6-month follow-up period using both electronic Case Report Form (eCRF) and electronic patient diary (specifically designed mobile/Web application). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Dexyane Med
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 7 Sep 2022to 7 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with an initial diagnosis of CHE and having been treated for a moderate to severe flare (i.e., equivalent to a grade 3 or 4 of the IGA scale) and who are clear or almost clear of HE (i.e., equivalent to a grade 0 or 1 of the IGA scale) at the moment of inclusion after treatment by topical or systemic treatment will be eligible for enrollment in the study.
Who may be able to join
- Patients aged ≥ 18 years at inclusion.
- Patients diagnosed with CHE (all types of HE admitted: contact, irritative, atopic, etc.) as defined as an eczematous process that lasts for more than three months, or relapses twice or more often per year.
- Patients clear or almost clear of HE at the time of inclusion (i.e., equivalent to a grade 0 or 1 of the IGA scale) after completing treatment (oral or systemic) for a HE flare within the month prior to inclusion.
- Patients having been prescribed with Dexyane MeD® alone or in association with Dexyane insulating barrier cream (the patient can either be a primo-user or a regular user of Dexyane MeD®).
- Patients having provided a signed informed consent.
Who cannot join
- Patients with another ongoing and evolutive hand skin condition (including psoriasis, and vitiligo).
- Patient with ongoing systemic immunosuppressive therapy.
- Patients participating in interventional trials on any investigational drug at the time of inclusion.
- Patients unable to understand and to comply with the study-related requirements (patient diary to be completed autonomously).
About this study
Prospective, descriptive, multicenter, real-world, international clinical investigation. Data collection is based on current clinical practice over a 6-month follow-up period using both electronic Case Report Form (eCRF) and electronic patient diary (specifically designed mobile/Web application). Based on current clinical practice, at least two milestone visits are anticipated with the possibility of intermediary visits in case of flare recurrence:
- inclusion visit (in-person visit) = Baseline = once clear or almost clear of HE after a moderate to severe flare requiring treatment;
- flare visit(s) (in-person or teleconsultation) = potential intermediary visit(s) required by the patient in case of HE flare, anticipated to occur anytime between inclusion visit and end of study visit;
- end of study visit (in-person or teleconsultation) = regular bi-annual visit for patients' follow-up as per clinical practice, anticipated to occur 6 months post-inclusion (-3 / + 1 months).
Read the detailed description
This clinical investigation will be a real-world, post-market, prospective, descriptive, multicenter, and international.
The clinical investigation is expected to take place in European countries (France, Spain, Italy, Portugal, and Germany are currently planned). Approximately 200 adult patients from approximately 35 centers (dermatologist practices) will be enrolled and followed for a total duration of 6 months (-3/+1 month). The aim of the study is to describe the patient's practice of Dexyane MeD® in CHE patients, for whom it has been prescribed either alone or in association with Dexyane insulating barrier cream, with no intention of group comparison.
All consecutive patients with moderate to severe CHE who are clear or almost clear of HE after being treated with topical or systemic treatment and who have been prescribed Dexyane MeD® (alone or in association with Dexyane insulating barrier), will be eligible to participate. The study will not provide or recommend any specific treatment procedures; all decisions regarding treatment of included patients will be made by the treating physician in accordance with their usual clinical practice.
Patients' data will be collected by the investigator from the date of prescription of Dexyane MeD® until the end of the observation period (6 months). All patients will be treated and monitored according to the local clinical practice. Based on a feasibility survey among dermatologists in public and/or private practice, at least two milestone visits are anticipated with the possibility of intermediary visits in case of flare recurrence:
- inclusion visit (in-person visit) = Baseline = once clear or almost clear of HE after a moderate to severe flare requiring treatment;
- flare visit(s) (in-person or teleconsultation) = potential intermediary visit(s) required by the patient in case of HE flare, anticipated to occur anytime between inclusion visit and end of study visit;
- end of study visit (in-person or teleconsultation) = regular bi-annual visit for patients' follow-up as per clinical practice, anticipated to occur 6 months post-inclusion (-3 / + 1 months).
Moreover, patients will be provided with all the adequate instructions to complete an electronic patient diary at inclusion (mobile app) and they will be encouraged to complete it throughout the 6-month observation period. Within this digital tool, an additional feature will allow the patient to send pictures of their hands to their physician in case of flare to assess the severity or for the physician to assess response to treatment. The patient will be adequately instructed to focus the picture on the hands only, in order that the picture remain anonymous and no personal data can be collected. The exchange of pictures is a current clinical practice to tackle the lack of appointment availability and has increased exponentially in the last years, in parallel to the increase of remote consultations.
- Conditions
- Chronic Hand Eczema
- Being tested
- Dexyane Med
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexyane MedDevice
Dexyane MeD® is a non-sterile topical cream, for external use only, available in 30 mL or 100 mL tubes (also available in sample model 5mL tubes).
| Study group | Role | What they receive |
|---|---|---|
| Dexyane Med | Dexyane MeD® is a non-sterile topical cream, for external use only, available in 30 mL or 100 mL tubes (also available in sample model 5mL tubes). Receives: Device: Dexyane Med |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days to first relapse of HE after being clear or almost clear of hand eczema
- severity score, and evolution from baseline, of each HE relapse event during the 6-month follow-up using the Investigator Global Assessment (IGA) scale, the modified Total Lesion Symptom Score (mTLSS) and the Chronic Itch Burden Scale
- number of relapse events observed per patient during the 6-month follow-up;
- number of days between subsequent HE relapse events during the 6-month follow-up;
- rate of patients in whom a relapse of HE was observed during the 6-month follow-up.
Measured: 6 months
Secondary outcomes (6)
Description of demographics and clinical profile of included patients
Description of demographics and clinical profile of included patients
Measured: 6 months
Description of scores from the Dermatology Life Quality Index (DLQI) at inclusion and at the end of the 6-month follow-up period.
Description of scores from the Dermatology Life Quality Index (DLQI) at inclusion and at the end of the 6-month follow-up period.
Measured: 6 months
Proportion of patients satisfied with Dexyane MeD® used with or without Dexyane insulating barrier cream, assessed via a specifically adapted questionnaire
Proportion of patients satisfied with Dexyane MeD® used with or without Dexyane insulating barrier cream, assessed via a specifically adapted questionnaire
Measured: 6 months
Proportion of patients adhering to the instructions for use
Proportion of patients adhering to the instructions for use (applications twice a day) on more that 75% of the days for which data are collected. This secondary outcome will be completed by detailed description of variables included in the patient diary and assessing the use of Dexyane MeD® with or without Dexyane insulating barrier cream.
Measured: 6 months
Proportion of patients in whom at least one relevant Adverse Device Effect (ADE) is observed. Relevant ADEs are defined as those leading to Dexyane MeD® or Dexyane insulating barrier cream discontinuation;
Proportion of patients in whom at least one relevant Adverse Device Effect (ADE) is observed. Relevant ADEs are defined as those leading to Dexyane MeD® or Dexyane insulating barrier cream discontinuation;
Measured: 6 months
Description of healthcare resources use due to CHE (consultations and treatment) and impact of CHE on work productivity assessed with the Work Productivity and Activity Impairment (WPAI) questionnaire.
Description of healthcare resources use due to CHE (consultations and treatment) and impact of CHE on work productivity assessed with the Work Productivity and Activity Impairment (WPAI) questionnaire.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start7 Sep 2022
- Primary completion7 Dec 2022
- Study completion7 Dec 2022
Why it stopped: no recruitment afetre several months, Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hand EczemaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pierre Fabre Medicament
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05545215
- Sponsor's protocol ID
- NIS12940
- Acronym
- CARING
- Status last verified
- Aug 2022
- First submitted
- 14 Sep 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real-World Clinical Investigation on Dexyane Med® in Adults With Chronic Hand Eczema
- ClinicalTrials.gov ID
- NCT05545215
- Acronym / sponsor ID
- CARING / NIS12940
- Conditions
- Chronic Hand Eczema
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no recruitment afetre several months, Sponsor decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pierre Fabre MedicamentIndustry (pharma, biotech, devices)
- Collaborators
- ClinSearch
- Study start
- 7 Sep 2022 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 7 Dec 2022 (actual)
- First posted
- 19 Sep 2022 (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.
Prospective, descriptive, multicenter, real-world, international clinical investigation. Data collection is based on current clinical practice over a 6-month follow-up period using both electronic Case Report Form (eCRF) and electronic patient diary (specifically designed mobile/Web application). Based on current clinical practice, at least two milestone visits are anticipated with the possibility of intermediary visits in case of flare recurrence:
- inclusion visit (in-person visit) = Baseline = once clear or almost clear of HE after a moderate to severe flare requiring treatment;
- flare visit(s) (in-person or teleconsultation) = potential intermediary visit(s) required by the patient in case of HE flare, anticipated to occur anytime between inclusion visit and end of study visit;
- end of study visit (in-person or teleconsultation) = regular bi-annual visit for patients' follow-up as per clinical practice, anticipated to occur 6 months post-inclusion (-3 / + 1 months).
Detailed description
This clinical investigation will be a real-world, post-market, prospective, descriptive, multicenter, and international.
The clinical investigation is expected to take place in European countries (France, Spain, Italy, Portugal, and Germany are currently planned). Approximately 200 adult patients from approximately 35 centers (dermatologist practices) will be enrolled and followed for a total duration of 6 months (-3/+1 month). The aim of the study is to describe the patient's practice of Dexyane MeD® in CHE patients, for whom it has been prescribed either alone or in association with Dexyane insulating barrier cream, with no intention of group comparison.
All consecutive patients with moderate to severe CHE who are clear or almost clear of HE after being treated with topical or systemic treatment and who have been prescribed Dexyane MeD® (alone or in association with Dexyane insulating barrier), will be eligible to participate. The study will not provide or recommend any specific treatment procedures; all decisions regarding treatment of included patients will be made by the treating physician in accordance with their usual clinical practice.
Patients' data will be collected by the investigator from the date of prescription of Dexyane MeD® until the end of the observation period (6 months). All patients will be treated and monitored according to the local clinical practice. Based on a feasibility survey among dermatologists in public and/or private practice, at least two milestone visits are anticipated with the possibility of intermediary visits in case of flare recurrence:
- inclusion visit (in-person visit) = Baseline = once clear or almost clear of HE after a moderate to severe flare requiring treatment;
- flare visit(s) (in-person or teleconsultation) = potential intermediary visit(s) required by the patient in case of HE flare, anticipated to occur anytime between inclusion visit and end of study visit;
- end of study visit (in-person or teleconsultation) = regular bi-annual visit for patients' follow-up as per clinical practice, anticipated to occur 6 months post-inclusion (-3 / + 1 months).
Moreover, patients will be provided with all the adequate instructions to complete an electronic patient diary at inclusion (mobile app) and they will be encouraged to complete it throughout the 6-month observation period. Within this digital tool, an additional feature will allow the patient to send pictures of their hands to their physician in case of flare to assess the severity or for the physician to assess response to treatment. The patient will be adequately instructed to focus the picture on the hands only, in order that the picture remain anonymous and no personal data can be collected. The exchange of pictures is a current clinical practice to tackle the lack of appointment availability and has increased exponentially in the last years, in parallel to the increase of remote consultations.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexyane Med | – | Device: Dexyane MedDexyane MeD® is a non-sterile topical cream, for external use only, available in 30 mL or 100 mL tubes (also available in sample model 5mL tubes). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with an initial diagnosis of CHE and having been treated for a moderate to severe flare (i.e., equivalent to a grade 3 or 4 of the IGA scale) and who are clear or almost clear of HE (i.e., equivalent to a grade 0 or 1 of the IGA scale) at the moment of inclusion after treatment by topical or systemic treatment will be eligible for enrollment in the study.
Key inclusion criteria (5 listed)
- Patients aged ≥ 18 years at inclusion.
- Patients diagnosed with CHE (all types of HE admitted: contact, irritative, atopic, etc.) as defined as an eczematous process that lasts for more than three months, or relapses twice or more often per year.
- Patients clear or almost clear of HE at the time of inclusion (i.e., equivalent to a grade 0 or 1 of the IGA scale) after completing treatment (oral or systemic) for a HE flare within the month prior to inclusion.
- Patients having been prescribed with Dexyane MeD® alone or in association with Dexyane insulating barrier cream (the patient can either be a primo-user or a regular user of Dexyane MeD®).
- Patients having provided a signed informed consent.
Key exclusion criteria (4 listed)
- Patients with another ongoing and evolutive hand skin condition (including psoriasis, and vitiligo).
- Patient with ongoing systemic immunosuppressive therapy.
- Patients participating in interventional trials on any investigational drug at the time of inclusion.
- Patients unable to understand and to comply with the study-related requirements (patient diary to be completed autonomously).
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 |
|---|---|---|
| Dexyane MedDexyane MeD® is a non-sterile topical cream, for external use only, available in 30 mL or 100 mL tubes (also available in sample model 5mL tubes). | Device | Dexyane Med |
Primary outcome
Number of days to first relapse of HE after being clear or almost clear of hand eczema
Time frame: 6 months
* severity score, and evolution from baseline, of each HE relapse event during the 6-month follow-up using the Investigator Global Assessment (IGA) scale, the modified Total Lesion Symptom Score (mTLSS) and the Chronic Itch Burden Scale * number of relapse events observed per patient during the 6-month follow-up; * number of days between subsequent HE relapse events during the 6-month follow-up; * rate of patients in whom a relapse of HE was observed during the 6-month follow-up.
6 secondary outcomes
Description of demographics and clinical profile of included patients
Time frame: 6 months
Description of scores from the Dermatology Life Quality Index (DLQI) at inclusion and at the end of the 6-month follow-up period.
Time frame: 6 months
Proportion of patients satisfied with Dexyane MeD® used with or without Dexyane insulating barrier cream, assessed via a specifically adapted questionnaire
Time frame: 6 months
Proportion of patients adhering to the instructions for use
Time frame: 6 months
Proportion of patients in whom at least one relevant Adverse Device Effect (ADE) is observed. Relevant ADEs are defined as those leading to Dexyane MeD® or Dexyane insulating barrier cream discontinuation;
Time frame: 6 months
Description of healthcare resources use due to CHE (consultations and treatment) and impact of CHE on work productivity assessed with the Work Productivity and Activity Impairment (WPAI) questionnaire.
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hand Eczema, run by Pierre Fabre Medicament.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of days to first relapse of HE after being clear or almost clear of hand eczema (time frame: 6 months). 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 12 Dec 2023.