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Clinical and Biological Characteristics of Hidradenitis Suppurativa

Sponsor
University of California, San Francisco (Other)
Overall Status
Recruiting
CT.gov ID
NCT03967600
Collaborator
(none)
1,000
Enrollment
1
Location
120
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical and Biological Characteristics of Hidradenitis Suppurativa
    Actual Study Start Date :
    Jul 15, 2016
    Anticipated Primary Completion Date :
    Jul 15, 2026
    Anticipated Study Completion Date :
    Jul 15, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Primary Outcome Measures

    1. The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa. [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. [2016-2026]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    13 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes

    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

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94115

    Sponsors and Collaborators

    • University of California, San Francisco

    Investigators

    • Principal Investigator: Haley B Naik, MD, MHSc, FAAD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT03967600
    Other Study ID Numbers:
    • 16-19770
    First Posted:
    May 30, 2019
    Last Update Posted:
    Jun 6, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis

    Study Results

    No Results Posted as of Jun 6, 2022