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Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository (HS PROGRESS)

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ClinicalTrials.gov Identifier: NCT04115566
Recruitment Status : Recruiting
First Posted : October 4, 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 : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
Actual Study Start Date : August 1, 2020
Estimated Primary Completion Date : September 1, 2029
Estimated Study Completion Date : September 1, 2029

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Primary Objective [ Time Frame: 2019-2029 ]
    The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa.


Secondary Outcome Measures :
  1. Secondary Objective [ Time Frame: 2019-2029 ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
HS Patients
Criteria

Inclusion Criteria:

  1. Male or female ≥ 10 years of age
  2. Diagnosis of HS by a dermatologist or practitioner experienced in making a diagnosis of HS
  3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Inability to give informed consent or unavailability of 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): NCT04115566


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
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: NCT04115566    
Other Study ID Numbers: 18-27002
First Posted: October 4, 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