Study type

Study topic

Disease /health condition

Study type

Non-interventional study

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

registry based cohort study
Study drug and medical condition

Medical condition to be studied

Dermatitis
Dermatitis atopic
Hand dermatitis
Eczema

Additional medical condition(s)

atopic foot eczema
Population studied

Short description of the study population

adult patients with moderate to severe atopic hand and/or foot eczema, who provide informed consent

Inclusion criteria:
- 18-100 years of age
- Consultation at one of the (German) study sites
- Confirmed diagnosis of aH&FE
- At least moderate AD of either hands or feet - assessed with Hand Eczema Severity Index (HECSI) ≥ 17 and/or Foot Eczema Severity Index (FECSI, analogous to HECSI)
- Indication of anti-inflammatory systemic therapy for aH&FE, or anti-inflammatory systemic therapy for aH&FE conducted within the past 24 months

Exclusion critieria:
- Insufficient German skills for completion of study questionnaires
- EASI ≥ 16

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

500
Study design details

Study design

prospective, multicenter, non-interventional, clinical, academic, national registry for adult patients suffering of moderate to severe atopic hand and/or foot eczema
standardized visit documentation takes place at routine care visits every 3 to 6 months in outpatient care

Main study objective

Primary objectives
- To establish a national, science-led clinical registry and research network
- To characterize medical care and pharmaceutical therapies in adults suffering from moderate-to-severe aH&FE
- To investigate the perspective of the patient (quality of life, POEM, itch, pain, sleep disturbance, ability to work, treatment satisfaction)
- To investigate the real-world efficacy of biologicals vs. conventional therapies, tolerability and safety of conventional and biologic treatment modalities, sequence of treatments, drug survival and change of treatments in patients suffering from moderate to severe aH&FE
- To register adverse events of systemic treatments in moderate to severe aH&FE

Setting

- Recruitment sites: dermatological hospitals, outpatient dermatologists with focus on aH&FE/ allergology/ atopic dermatitis in Germany, after site initiation

- No study related intervention will be performed.
- Included patients will be prospectively followed. A maximum duration of follow-up is not intended.
- Standardized study visits are performed during routine care visits to prospectively document patient characteristics, clinical data, patient-reported outcomes, physicians’ reasons for treatment decisions, and satisfaction with treatment, about every 3 to 6 month, additional visits possible 4-weeks after start of new therapy.

Outcomes

All results will be reported in aggregated form so that no conclusions can be drawn about individual patients.

Primary Endpoints:
In analogy to the recommendations of the HOME initiative, we consider changes in the following primary endpoints for real-world efficacy of applied therapies:
- Objective severity of clinical signs, in ReaCT measured with HECSI-50, HECSI-75, and HECSI-90 six months after treatment was first prescribed (analogue analyses concerning FE)
- Patient-reported symptoms measured with POEM six months after treatment was first prescribed
- Disease control over time measured with RECAP six months after treatment was first prescribed
- Quality of life measured with HEIS six months after treatment was first prescribed

Another primary endpoint is the safety of applied treatments at each visit.

Secondary Endpoints:
- Impact of applied treatment on primary endpoints: biologics vs conventional treatment
- Impact of potential risk factors on primary endpoints
- Proportion of treatment response and duration of response based on IGA changes
- Disease modification measured as complete remission and number of flares since latest consultation on hands and feet, respectively, HECSI, FE severity, EASI, IGA, RECAP, POEM, DLQI, PGA, WPAI, pruritus NRS, pain NRS, sleep disturbance NRS, depression CES-D

Data analysis plan

Data analysis is descriptive and explorative. Because ReaCT aH&FE is a non-interventional study (observational study), no confirmatory statistical analysis is carried out.