ClinicalTrials.gg
CompletedNCT03289585Updated Mar 3, 2023

A National Registry For Patients With Hidradenitis Suppurativa

An observational study in Hidradenitis Suppurativa, 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 2023-03-03.

Sponsored by Montefiore Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
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 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.

Read the 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.

02

Conditions studied

  • Hidradenitis Suppurativa

Keywords

  • Hidradenitis Suppurativa
  • Registry
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) with a diagnosis of Hidradenitis Suppurativa

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

  • 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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
400 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Skin-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. Skin-related 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 the 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

    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 is no plan to share individual participant data to other researchers

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2015 to primary completion in Sep 2022, 85 months.

Of 43 observational studies under Hidradenitis Suppurativa, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 28. This study's 85 months is above that.

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

Registered
Sep 11, 2017
First posted
Sep 21, 2017
StartActual
Aug 2015
Primary completionActual
Sep 6, 2022
CompletionActual
Sep 6, 2022
Last update
Mar 3, 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 Mar 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03289585
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Aug 2015
Primary completion
Sep 6, 2022
Completion
Sep 6, 2022
Last update
Mar 3, 2023

Study contacts

Steven R Cohen, MD, MPH
principal investigator · Albert Einstein College of Medicine Montefiore Medical Center

Oversight

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

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion