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

NCT05545215 | Withdrawn FDA Device

• 1 other identifier: NIS12940
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (6)

• Description of demographics and clinical profile of included patients

  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.

  6 months

• Proportion of patients satisfied with Dexyane MeD® used with or without Dexyane insulating barrier cream, assessed via a specifically adapted questionnaire

  6 months

• Proportion of patients adhering to the instructions for use

  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;

  6 months

Study Arms (1)

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).

Device: Dexyane Med

Interventions

Dexyane Med 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).

Dexyane Med

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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 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.

You may not qualify if:

• Patients with another ongoing and evolutive hand skin condition (including psoriasis, and vitiligo).
• Patient with ongoing systemic immunosuppressive therapy.
• Patients unable to understand and to comply with the study-related requirements (patient diary to be completed autonomously).

Sponsors & Collaborators

• Pierre Fabre Medicament: lead
• ClinSearch: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 19, 2022
• Study Start: September 7, 2022
• Primary Completion: December 7, 2022
• Study Completion: December 7, 2022
• Last Updated: December 12, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share