Real-World Study on the Burden of Hidradenitis Suppurativa

December 22, 2025 updated by: PeriPharm
Despite the significant impact of HS on patients' quality of life (QoL) and daily functioning, there remains limited real-world evidence describing the burden of this condition in Canada. HS is an under-recognized and often misdiagnosed condition, with a substantial psychological and physical burden on patients. Understanding the real-world experiences of individuals living with HS in Canada can help identify unmet needs and inform patient-centered care approaches.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients with HS

Description

Inclusion Criteria:

  1. Patient diagnosed with HS;
  2. Aged ≥18 years;
  3. Able to read and understand French or English;
  4. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Participation in an interventional study for HS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patient with HS
Patient diagnosed with HS
Other: No Intervention: Observational Cohort
No specific intervention is assess in this study. Observational cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate work productivity loss in patients with HS.
Time Frame: At recruitment
Using the Work Productivity and Activity Impairment (WPAI) questionnaire. This questionnaire provides a quantitative measure of impairment over the last 7 days and includes four metrics: absenteeism (work time missed because of health issues during the past 7 days), presenteeism (impairment while working due to health issues during the past 7 days), overall work productivity loss (combination of absenteeism and presenteeism), and activity impairment.
At recruitment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To estimate the QoL of patients with HS
Time Frame: At recruitment
The Hidradenitis Suppurativa Quality of Life Questionnaire (HiSQOL) is a validated, HS-specific instrument designed to capture the multidimensional impact of HS on quality of life over the previous 7 days. It consists of 17 items that use Likert-type response options, ranging from 0 ("not at all") to 4 ("extremely"), with some items allowing respondents to indicate that an activity was not performed due either to lack of relevance or HS severity
At recruitment
To estimate pain intensity in patients with HS.
Time Frame: At recruitment
Patients with HS will self-report the worst intensity of their pain over the past 7 days using an 11-point numeric rating scale (NRS). The NRS ranges from 0 ("No Pain") to 10 ("The worst imaginable Pain"). Pain was selected as a key symptom given its substantial impact on patients' daily lives and QoL. The 7-day recall period was chosen to balance recall accuracy and symptom variability, capturing recent disease activity while minimizing recall bias.
At recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeriPharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROxy85HS

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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