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Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER) (QUALIVER)

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ClinicalTrials.gov Identifier: NCT05986825
Recruitment Status : Recruiting
First Posted : August 14, 2023
Last Update Posted : September 14, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Study Description
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Brief Summary:
Validation of the French Version of the Score on Quality of Life in Hidradenitis Suppurativa. The French HiSQOL will be completed by 60 patients with hidradenitis suppurativa a first time, and a second time 1 week later.

Condition or disease Intervention/treatment
Hidradenitis Suppurativa Other: Verneuil questionnaire Validation

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Validation of the French Version of the Score on Quality of Life (HiSQOL) in Hidradenitis Suppurativa (QUALIVER)
Actual Study Start Date : August 29, 2023
Estimated Primary Completion Date : September 2024
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Experimental
Patients with Verneuil disease
 Other: Verneuil questionnaire Validation
Request patient to Complete the questionnaire for validation of the French version


Outcome Measures
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Primary Outcome Measures :
  1. Validation of the questionnaire [ Time Frame: During the visit and 1 week later ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Verneuil disease
Criteria

Inclusion Criteria:

  • Age ≥18 years
  • Patient with Verneuil disease
  • Beneficiary of or affiliated to a social security insurance
  • Participation agreement

Exclusion Criteria:

  • Patients physically or mentally unable to complete questionnaires.
  • Refusal to participate
  • Patient under legal protection (guardianship, curatorship) or deprived of liberty
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05986825


Contacts
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Contact: Emilie BRENAUT, PH +33298223315 emilie.brenaut@univ-brest.fr
Contact: Sébastien BERROS +33298223315 sebastien.berros@chu-brest.fr

Locations
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France
CHU Brest Recruiting
Brest, France, 29200
Contact: Emilie BRENAUT, PH       emilie.brenaut@univ-brest.fr   
Principal Investigator: Emilie BRENAUT, PH         
Sponsors and Collaborators
University Hospital, Brest
More Information
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT05986825    
Other Study ID Numbers: 29BRC22.0225 (QUALIVER)
First Posted: August 14, 2023    Key Record Dates
Last Update Posted: September 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All collected data that underlie results in a publication
Supporting Materials: Study Protocol
Time Frame: All collected data that underlie results in a publication
Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
 Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration