Hidradenitis SuppurativaNCT03289585
A National Registry For Patients With Hidradenitis Suppurativa
An observational study of Hidradenitis Suppurativa, run by Montefiore Medical Center at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 6 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Adult, Older adult
Study population: Healthy adults (ages 18-99) with a diagnosis of Hidradenitis Suppurativa
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore Medical Center
The Bronx, New York, 10467
About this study
Official title: 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.
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.
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Registry
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Skin-related quality of life
Quality of life as measured using standardized Dermatology Quality of Life Index
Measured: Baseline
Presence and severity of depression
Presence and severity of depression as measured using standardized Beck Depression Inventory
Measured: Baseline
Skin-related of life
Quality of life as measured using standardized SkinDex questionnaires
Measured: Baseline
Subject-reported subject health
Subject-reported subject health as measured using the standardized SF-36 questionnaires
Measured: 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.
Measured: Baseline
Employment and economic productivity
Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
Measured: Baseline
Secondary outcomes (6)
Change in quality of life
Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation
Measured: At 6 months
Change in presence and severity of depression
Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation
Measured: At 6 months
Change in quality of life
Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation
Measured: At 6 months
Change in subject-reported subject health
Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation
Measured: At 6 months
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
Measured: At 6 months
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
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study startAug 2015
- Primary completion6 Sep 2022
- Study completion6 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Cohen, MD, MPH, Principal investigator, Albert Einstein College of Medicine Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03289585
- Sponsor's protocol ID
- 2014-3835 (AECOM)
- Status last verified
- Mar 2023
- First submitted
- 11 Sep 2017
- Last updated
- 3 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Maintenance of a National Registry For Patients With Hidradenitis Suppurativa
- ClinicalTrials.gov ID
- NCT03289585
- Acronym / sponsor ID
- 2014-3835 (AECOM)
- Conditions
- Hidradenitis Suppurativa
- Keywords
- Hidradenitis Suppurativa, Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Study start
- Aug 2015 (actual)
- Primary completion
- 6 Sep 2022 (actual)
- Study completion
- 6 Sep 2022 (actual)
- First posted
- 21 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy adults (ages 18-99) with a diagnosis of Hidradenitis Suppurativa
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Skin-related quality of life
Time frame: Baseline
Quality of life as measured using standardized Dermatology Quality of Life Index
Presence and severity of depression
Time frame: Baseline
Presence and severity of depression as measured using standardized Beck Depression Inventory
Skin-related of life
Time frame: Baseline
Quality of life as measured using standardized SkinDex questionnaires
Subject-reported subject health
Time frame: Baseline
Subject-reported subject health as measured using the standardized SF-36 questionnaires
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.
Employment and economic productivity
Time frame: Baseline
Self-reported employment and economic productivity as measured by a standardized health economic questionnaire
6 secondary outcomes
Change in quality of life
Time frame: At 6 months
Change in presence and severity of depression
Time frame: At 6 months
Change in quality of life
Time frame: At 6 months
Change in subject-reported subject health
Time frame: 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 self-reported employment and economic productivity
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Montefiore Hidradenitis Suppurativa Multispecialty Treatment CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data to other researchers
Related trials for Hidradenitis Suppurativa
Not yet recruiting
Early Pathophysiology of Hidradenitis Suppurativa and Prediction of the Risk of Progression: a Prospective Cohort
Hidradenitis Suppurativa (HS)
Active, not recruitingPhase 2
A Study of Zasocitinib in Adults With Hidradenitis Suppurativa
Hidradenitis Suppurativa
Active, not recruiting
Acceptability of MBSR for People With HS
Hidradenitis Suppurativa (HS)
RecruitingPhase 3
Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib
Hidradenitis Suppurativa (HS)
RecruitingPhase 2
ORKA-002 Versus Placebo in Participants With Moderate-to-Severe Hidradenitis Suppurativa
Hidradenitis Suppurativa (HS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven R Cohen, MD, MPH principal investigator
Albert Einstein College of Medicine Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hidradenitis Suppurativa, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin-related quality of life (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023.