WithdrawnNot Applicable

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

Stopped: no recruitment afetre several months, Sponsor decision

0Started 2022-09-07

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

What they're measuring

Number of days to first relapse of HE after being clear or almost clear of hand eczema

Timeframe: 6 months

Trial details

NCT IDNCT05545215

SponsorPierre Fabre Medicament

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-12-07