Trial document




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  DRKS00025315

Trial Description

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Title

Epidemiology and Care in Acne inversa

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Trial Acronym

EpiCAi

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URL of the Trial

http://www.epicai.de

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Brief Summary in Lay Language

EpiCAi (Epidemiology and Care in Acne inversa) is a project of an international consortium of experts led by the Department of Dermatology of the University Medical Center Mainz in cooperation with LENICURA GmbH.
The aim of the EpiCAi project is to combine data from the everyday care of a large number of acne inversa (hidradenitis suppurativa) patients with digital surveys.
The analysis of the questionnaires will provide new insights into patient pathways through the health care system, disease progression, recurrence frequency, trigger factors, risk factors, quality of life, effectiveness of therapies and others. The study will be able to contribute significantly to improved disease management.

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Brief Summary in Scientific Language

The aim of the EpiCAi project is to combine retrospective routine data from a large cohort of acne inversa (hidradenitis suppurativa) patients with a prospective survey.
The analyses are expected to provide new insights into patient pathways through the healthcare system, disease progression, recurrence frequency, trigger factors, risk factors, quality of life, effectiveness of therapies and others. The study will be able to contribute significantly to improved disease management.

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Do you plan to share individual participant data with other researchers?

No

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Description IPD sharing plan:

The Department of Dermatology at the University Medical Center Mainz and the other researchers in the expert consortium will publish the results of the study when it is completed.

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Organizational Data

  •   DRKS00025315
  •   2021/06/17
  •   [---]*
  •   yes
  •   Approved
  •   2021-15884, Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   L73.2 -  Hidradenitis suppurativa
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Interventions/Observational Groups

  •   All patients who have agreed to the documentation of their treatment with LAight® therapy in the LENICURA software will be invited to participate in the study. This is done on the one hand by mail to the mail address provided by the patient for research purposes and on the other hand by displaying flyers at the treatment sites of the LAight® therapy and describing the project on the project website (www.epicai.de).
    After logging in to their own account, patients will be shown questionnaires. All questionnaires are displayed at t0 and some are repeated again after 3 and 6 months.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Health care system
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The study is expected to provide new insights into patient pathways through the healthcare system, disease progression, recurrence frequency, trigger factors, risk factors, quality of life, effectiveness of therapies, and other.

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Secondary Outcome

None

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2021/12/03
  •   2000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Acne inversa (hidradenitis suppurativa) of all severities (Hurley I-III)
2. Patient is treated with LAight® and documented via the software
3. Smartphone or tablet with access to the patient portal of the software

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Exclusion Criteria

Insufficient knowledge of the German language

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • LENICURA GmbH
    • Dwight-D.-Eisenhower-Straße 9
    • 65197  Wiesbaden
    • Germany
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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Mr.  Dr.  Michael  Schultheis 
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • LENICURA GmbH
    • Ms.  Dr. rer. pol.  Katharina  Reinhard 
    • Dwight-D.-Eisenhower-Straße 9
    • 65197  Wiesbaden
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
  •   [---]*
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  •   3513
  •   3513
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.