A National Registry For Patients With Hidradenitis Suppurativa

NCT03289585 | Completed

• 1 other identifier: 2014-3835 (AECOM)
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Keywords

Hidradenitis Suppurativa; Registry

Outcome Measures

Primary Outcomes (6)

• Skin-related quality of life

  Quality of life as measured using standardized Dermatology Quality of Life Index

  Baseline

• Presence and severity of depression

  Presence and severity of depression as measured using standardized Beck Depression Inventory

  Baseline

• Skin-related of life

  Quality of life as measured using standardized SkinDex questionnaires

  Baseline

• Subject-reported subject health

  Subject-reported subject health as measured using the standardized SF-36 questionnaires

  Baseline

• Degree of enjoyment and satisfaction experienced by subjects in daily functioning.

  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

  Self-reported employment and economic productivity as measured by a standardized health economic questionnaire

  Baseline

Secondary Outcomes (6)

• Change in quality of life

  At 6 months

• Change in presence and severity of depression

  At 6 months

• Change in quality of life

  At 6 months

• Change in subject-reported subject health

  At 6 months

• Change in degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning

  At 6 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Related Links

• Montefiore Hidradenitis Suppurativa Multispecialty Treatment Center

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Steven R Cohen, MD, MPH

  Albert Einstein College of Medicine Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: September 21, 2017
• Study Start: August 1, 2015
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: March 3, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)