A National Registry For Patients With Hidradenitis Suppurativa

March 1, 2023 updated by: Montefiore Medical Center

Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa

The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. The investigators hope this information will help improve treatment for this skin condition.

Study Overview

Status

Completed

Conditions

Detailed Description

The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. The investigators will utilize a compilation of validated questionnaires including the Beck Depression Inventory form, Dermatology Life Quality Index (DLQI), Skindex, SF-36 health survey, the Quality of Life Enjoyment and Satisfaction Questionnaire- short form (Q-LES-Q-SF) and the Employment/Productivity Health Economic Questionnaire as well as other relevant clinical data. The investigators will additionally collect a modified Hidradenitis Suppurativa Lesion, Area, and Severity Index (HS-LASI) (or other appropriate disease severity score as determined by the team) from the physician of each enrollee. The investigators hope this information will help improve treatment for this skin condition.

Study Type

Observational

Enrollment (Actual)

400

Contacts and Locations

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

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center

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

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adults (ages 18-99) with a diagnosis of Hidradenitis Suppurativa

Description

Inclusion Criteria:

  • Subjects 18-99 years of age who have a diagnosis of Hidradenitis Suppurativa (as deemed by a physician at the Montefiore Hidradenitis Suppurativa Treatment Center)

Exclusion Criteria:

  • Patients without a diagnosis of Hidradenitis Suppurativa or under the age of 18
  • Patients who are unable to answer given questions within the 6 surveys
  • Patient who are unable to be clinically evaluated by a Montefiore physician

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Hidradenitis Suppurativa Cohort
Patients with Hidradenitis Suppurativa (ages 18-99 years old) will be asked to complete a series of questionnaires on how Hidradenitis Suppurativa impacts quality of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Skin-related quality of life
Time Frame: Baseline
Quality of life as measured using standardized Dermatology Quality of Life Index
Baseline
Presence and severity of depression
Time Frame: Baseline
Presence and severity of depression as measured using standardized Beck Depression Inventory
Baseline
Skin-related of life
Time Frame: Baseline
Quality of life as measured using standardized SkinDex questionnaires
Baseline
Subject-reported subject health
Time Frame: Baseline
Subject-reported subject health as measured using the standardized SF-36 questionnaires
Baseline
Degree of enjoyment and satisfaction experienced by subjects in daily functioning.
Time Frame: Baseline
Degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning as measured by the standardized Quality of Life Enjoyment and Satisfaction Questionnaire-short form.
Baseline
Employment and economic productivity
Time Frame: Baseline
Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in quality of life
Time Frame: At 6 months
Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation
At 6 months
Change in presence and severity of depression
Time Frame: At 6 months
Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation
At 6 months
Change in quality of life
Time Frame: At 6 months
Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation
At 6 months
Change in subject-reported subject health
Time Frame: At 6 months
Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation
At 6 months
Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning
Time Frame: At 6 months
Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning as measured by the standardized Quality of Life Enjoyment and Satisfaction Questionnaire-short form after treatment initiation
At 6 months
Change in self-reported employment and economic productivity
Time Frame: At 6 months
Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation
At 6 months

Collaborators and Investigators

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

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Steven R Cohen, MD, MPH, Albert Einstein College of Medicine/Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 (Actual)

August 1, 2015

Primary Completion (Actual)

September 6, 2022

Study Completion (Actual)

September 6, 2022

Study Registration Dates

First Submitted

September 11, 2017

First Submitted That Met QC Criteria

September 18, 2017

First Posted (Actual)

September 21, 2017

Study Record Updates

Last Update Posted (Estimate)

March 3, 2023

Last Update Submitted That Met QC Criteria

March 1, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-3835 (AECOM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data to other researchers

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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