Prospective Real-World Clinical Investigation on Dexyane Med® in Adults With Chronic Hand Eczema

NCT ID: NCT05545215

Last Updated: 2023-12-12

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2022-12-07

Brief 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). 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.

Conditions

Chronic Hand Eczema

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

Dexyane Med

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinSearch

OTHER

Sponsor Role: collaborator

Pierre Fabre Medicament

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NIS12940

Identifier Type: -

Identifier Source: org_study_id