Epidemiology and Care in Acne inversa
Organizational Data
- DRKS-ID:
- DRKS00025315
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2021-06-17
- Last update in DRKS:
- 2024-02-15
- Registration type:
- Prospective
Acronym/abbreviation of the study
EpiCAi
URL of the study
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.
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.
Health condition or problem studied
- ICD10:
- L73.2 - Hidradenitis suppurativa
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- 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.
Endpoints
- 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.
- Secondary outcome:
- None
Study Design
- Purpose:
- Health care system
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- Epidemiological study
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Mainz
Recruitment period and number of participants
- Planned study start date:
- 2021-12-03
- Actual study start date:
- 2021-12-03
- Planned study completion date:
- 2023-01-18
- Actual Study Completion Date:
- 2023-01-18
- Target Sample Size:
- 2000
- Final Sample Size:
- 3513
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- 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
Exclusion Criteria
Insufficient knowledge of the German language
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin der Johannes Gutenberg-Universität MainzLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49-6131-17-5732
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinik.uni-mainz.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsmedizin der Johannes Gutenberg-Universität MainzDr. Michael SchultheisLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49-6131-17-5732
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinik.uni-mainz.de
Contact for Public Queries
- Address:
- LENICURA GmbHDr. rer. pol. Katharina ReinhardDwight-D.-Eisenhower-Straße 965197 WiesbadenGermany
- Telephone:
- +49611 95008500
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.laight.de
Principal Investigator
- Address:
- Universitätsmedizin der Johannes Gutenberg-Universität MainzDr. Michael SchultheisLangenbeckstraße 155131 MainzGermany
- Telephone:
- +49-6131-17-5732
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinik.uni-mainz.de
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsmedizin der Johannes Gutenberg-Universität MainzLangenbeckstraße 155131 MainzGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.klinik.uni-mainz.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission bei der Landesärztekammer Rheinland-PfalzDeutschhausplatz 355116 MainzGermany
- Telephone:
- +49-6131-288220
- Fax:
- +49-6131-2882266
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2021-05-12
- Ethics committee number:
- 2021-15884
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-06-07
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- 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.
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- Mann C, Staubach P, Grabbe S, Wegner J, Hennig K, Nikolakis G, Szepietowski JC, Matusiak L, von Stebut E, Kirschner U, Podda M, Garcovich S, Schultheis M. Self-management-competency as a new target in Hidradenitis suppurativa care. J Dermatolog Treat. 2023 Dec;34(1):2245082. doi: 10.1080/09546634.2023.2245082. PMID: 37577779.
- Krajewski PK, Strobel A, Schultheis M, Staubach P, Grabbe S, Hennig K, Matusiak L, von Stebut E, Garcovich S, Bayer H, Heise M, Kirschner U, Nikolakis G, Szepietowski JC. Hidradenitis suppurativa is associated with severe sexual impairment. Dermatology. 2024 Jan 8.
- Date of first publication of study results:
- 2023-08-14
- DRKS entry published for the first time with results:
- 2023-12-20
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry