Clinical and Biological Characteristics of Hidradenitis S... | NCT03967600

Studies
Clinical and Biological Characteristics of Hidradenitis Suppurativa

NCT03967600

Sponsor

University of California, San Francisco

Status

Recruiting

Last Update Posted

May 4, 2026Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Hidradenitis Suppurativa

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2016Actual

Primary Completion Date

Jul 15, 2026Estimated

Completion Date

Jul 15, 2026Estimated

First Submitted Date

May 27, 2019

First Submission Date that Met QC Criteria

May 27, 2019

First Posted Date

May 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2026

Last Update Posted Date

May 4, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Hidradenitis Suppurativa Patients		Patients with physician diagnosed Hidradenitis Suppurativa
Healthy Volunteers		Healthy volunteers without any skin conditions or recent history of antibiotic use.

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Hidradenitis Suppurativa Patients

Inclusion Criteria:

Age 13 years or older
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:

No history of chronic skin conditions
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

13 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with Hidradenitis Suppurativa

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kaelin Chatterley	Contact	415-961-3786		Kaelin.Chatterley@ucsf.edu

Overall Officials

Name	Affiliation	Role
Haley B Naik, MD, MHSc, FAAD	University of California, San Francisco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, San Francisco	Recruiting	San Francisco	California	94115	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D017497	Hidradenitis Suppurativa

Ancestor Terms

ID	Term
D017192	Skin Diseases, Bacterial
D001424	Bacterial Infections
D001423	Bacterial Infections and Mycoses
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided