ClinicalTrials.gg
CompletedNCT03288337Updated Jan 20, 2023

Impact of Hidradenitis Suppurativa on Quality of Life Functions

An observational study in Hidradenitis Suppurativa and Quality of Life, sponsored by Montefiore Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-01-20.

Sponsored by Montefiore Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Ages
18 Years to 99 Years
Sex
All
01

Study summary

The goal of this study is to get a better understanding of the impact of Hidradenitis Suppurativa (HS) on the quality of life of patients with this condition. Patients with HS will be asked questions about demographics including gender, age, and ethnicity. They will also be asked to complete questionnaires to determine how their skin condition affects their life. Study participation will last for 1 day, with potential for follow-up in the future. We hope this information will help us improve our treatment for this skin condition.

Read the detailed description

The goal of this study is to get a better understanding of the impact of the skin condition, Hidradenitis Suppurativa, on quality of life function of patients. Patients with HS will be asked questions about demographics including gender, age, and ethnicity. They will also be asked to complete questionnaires to determine how their skin condition affects their life. The questionnaires include Beck Depression Inventory form, which gives us information how you feel about your skin condition and how it changes your mood; Dermatology Life Quality Index (DLQI), which gives us information about how your skin condition affects your quality of life; Skindex, which gives us more specific information about how your skin condition affects your quality of life; SF-36 health survey, which gives us information about your general health status; the Quality of Life Enjoyment and Satisfaction Questionnaire- short form (Q-LES-Q-SF), which gives us information on your enjoyment and satisfaction of your life; and the Employment/Productivity Health Economic Questionnaire, which will give us more information on your work and school status as well as household income. Study participation will last for 1 day, with potential for follow-up in the future. Through potential follow up visits we hope to determine the longitudinal effect of treatment modalities on QoL through future survey performance of the patient cohort. We hope this information will help us improve our treatment for this skin condition.

02

Conditions studied

  • Hidradenitis Suppurativa
  • Quality of Life

Keywords

  • Hidradenitis Suppurativa
  • Quality of Life
03

In context

Hidradenitis Suppurativa

280 studies on the registry are indexed under Hidradenitis Suppurativa; 85 are open to participants now.

This study's enrollment of 400 is above the median of 165 across 71 observational studies indexed under Hidradenitis Suppurativa.

Browse Hidradenitis Suppurativa studies →

Lead sponsor

Montefiore Medical Center is the lead sponsor of 414 studies on the registry; 69 are open to participants now.

Of its 86 completed or terminated interventional studies of FDA-regulated products, 76 (88%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Healthy adults (ages 18-99) who have a diagnosis of HS (as deemed by a physician at the Hidradenitis Suppurativa Treatment Center at Montefiore Medical Center)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of hidradenitis suppurativa
  • Subject age >/= 18 years
  • Able to be evaluated by a Montefiore physician

Exclusion criteria

Exclusion Criteria:

  • No clinical diagnosis of hidradenitis suppurativa
  • Subject age \< 18 years
  • Subject unable to understand or answer provided questionnaires
  • Unable to evaluated by a Montefiore physician
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Hidradenitis Suppurativa Cohort

    Patients with HS who are eligible to fill out the series of quality of life questionnaires

06

What researchers measure

Primary outcomes

  1. Dermatology-related quality of life

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

    Time frame: Baseline

  2. Presence and severity of depression

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

    Time frame: Baseline

  3. Dermatology-related quality of life

    Quality of life as measured using standardized SkinDex questionnaires

    Time frame: Baseline

  4. Subject-reported subject health

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

    Time frame: Baseline

  5. 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.

    Time frame: Baseline

  6. Employment and economic productivity

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

    Time frame: Baseline

Secondary outcomes

  1. Change in quality of life

    Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation

    Time frame: At 6 months

  2. Change in presence and severity of depression as measured using standardized Beck Depression Inventory

    Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation

    Time frame: At 6 months

  3. Change in quality of life

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

    Time frame: At 6 months

  4. Change in subject-reported subject health

    Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation

    Time frame: At 6 months

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

    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

    Time frame: At 6 months

  6. Change in self-reported employment and economic productivity

    Change in self-reported employment and economic productivity as measured by a standardized health economic questionnaire after treatment initiation

    Time frame: At 6 months

07

Study locations

1 site
  • Montefiore Medical Center
    The Bronx, New York 10467, United States
08

References and documents

Individual participant data

Plan to share: No — There are no plans to share individual participant data to other researchers

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2015 to primary completion in Sep 2022, 89 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 20, 2017
StartActual
Apr 2015
Primary completionActual
Sep 6, 2022
CompletionActual
Sep 6, 2022
Last update
Jan 20, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03288337
Collaborators
AbbVie
Responsible party
Sponsor
First posted
Sep 20, 2017
Start date
Apr 2015
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022
Last update
Jan 20, 2023

Study contacts

Steven Cohen, MD. MPH
principal investigator · Momtefiore Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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