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Clinical and Biological Characteristics of Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT03967600
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : June 6, 2022
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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Brief Summary:
Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.

Condition or disease
Hidradenitis Suppurativa

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Clinical and Biological Characteristics of Hidradenitis Suppurativa
Actual Study Start Date : July 15, 2016
Estimated Primary Completion Date : July 15, 2026
Estimated Study Completion Date : July 15, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Hidradenitis Suppurativa Patients
Patients with physician diagnosed Hidradenitis Suppurativa
Healthy Volunteers
Healthy volunteers without any skin conditions or recent history of antibiotic use.


Outcome Measures
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Primary Outcome Measures :
  1. The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa. [ Time Frame: 2016-2026 ]

Secondary Outcome Measures :
  1. Secondary aims include correlating alterations in clinical and biological characteristics with disease status, and identifying genetic variants that predict disease progression or response to therapy. [ Time Frame: 2016-2026 ]

Eligibility Criteria
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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Hidradenitis Suppurativa
Criteria

Hidradenitis Suppurativa Patients

Inclusion Criteria:

  1. Age 13 years or older
  2. Diagnosis of HS clinically-confirmed by a physician

Exclusion Criteria:

1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.

Healthy Volunteer

Inclusion Criteria:

  1. No history of chronic skin conditions
  2. No recent history of antibiotic use

Exclusion Criteria:

1. Inability to give informed consent or have a parent/guardian who is able and willing to give informed consent.

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): NCT03967600


Contacts
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Contact: Hannah Balter 415-502-4741 hannah.balter@ucsf.edu

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94115
Contact: Maia Paul, MPH    415-502-4741    Maia.Paul@ucsf.edu   
Principal Investigator: Haley B Naik, MD, MHSc, FAAD         
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Haley B Naik, MD, MHSc, FAAD University of California, San Francisco
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03967600    
Other Study ID Numbers: 16-19770
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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