Skip to main content
OpenTrials
Completed

NCT Number: NCT03289585

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Skin-related quality of life

    Time frame: Baseline

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

  2. Presence and severity of depression

    Time frame: Baseline

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

  3. Skin-related of life

    Time frame: Baseline

    Quality of life as measured using standardized SkinDex questionnaires

  4. Subject-reported subject health

    Time frame: Baseline

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

  5. 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.

  6. Employment and economic productivity

    Time frame: Baseline

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

Secondary outcomes

  1. 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

  2. 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

  3. Change in quality of life

    Time frame: At 6 months

    Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Sep 21, 2017
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.