Clinical and Biological Characteristics of Hidradenitis Suppurativa

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.

Study Overview

• Status: Recruiting
• Conditions: Hidradenitis Suppurativa

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Hannah Balter; Phone Number: 415-502-4741; Email: hannah.balter@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • University of California, San Francisco
      • Contact: Maia Paul, MPH; Phone Number: 415-502-4741; Email: Maia.Paul@ucsf.edu
      • Principal Investigator: Haley B Naik, MD, MHSc, FAAD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with Hidradenitis Suppurativa

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary aim of this study is to identify clinical and biologic characteristics of hidradenitis suppurativa.	2016-2026

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2016
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): July 15, 2026

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (Actual): May 30, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: 16-19770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No