An observational study in Chronic Hand Eczema, sponsored by Pierre Fabre Medicament. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-12.
Sponsored by Pierre Fabre Medicament · Observational
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:
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:
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.
1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.
Browse Eczema studies →Pierre Fabre Medicament is the lead sponsor of 71 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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).
Device: 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).
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.
Time frame: 6 months
Description of demographics and clinical profile of included patients
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.
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
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
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.
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;
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.
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
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Pierre Fabre Medicament