A National Registry For Patients With Hidradenitis Suppurativa

Hidradenitis Suppurativa Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03289585
• Other study ID #: 2014-3835 (AECOM)
• Status: Completed
• Start date: August 2015
• Est. completion date: September 6, 2022

Study information

• Verified date: March 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: September 6, 2022
• Est. primary completion date: September 6, 2022
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin-related quality of life	Quality of life as measured using standardized Dermatology Quality of Life Index	Baseline
Primary	Presence and severity of depression	Presence and severity of depression as measured using standardized Beck Depression Inventory	Baseline
Primary	Skin-related of life	Quality of life as measured using standardized SkinDex questionnaires	Baseline
Primary	Subject-reported subject health	Subject-reported subject health as measured using the standardized SF-36 questionnaires	Baseline
Primary	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
Primary	Employment and economic productivity	Self-reported employment and economic productivity as measured by a standardized health economic questionnaire	Baseline
Secondary	Change in quality of life	Change in quality of life as measured using standardized Dermatology Quality of Life Index after treatment initiation	At 6 months
Secondary	Change in presence and severity of depression	Change in presence and severity of depression as measured using standardized Beck Depression Inventory after treatment initiation	At 6 months
Secondary	Change in quality of life	Change in quality of life as measured using standardized SkinDex questionnaires after treatment initiation	At 6 months
Secondary	Change in subject-reported subject health	Change in subject-reported subject health as measured using standardized SF-36 questionnaires after treatment initiation	At 6 months
Secondary	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	At 6 months
Secondary	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	At 6 months

External Links

•   Montefiore Hidradenitis Suppurativa Multispecialty Treatment Center