Sponsor study identifier
observational
67
1 country
1
Study Start
May 14, 2018
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
January 22, 2025
Actual (reported)Hidradenitis Suppurativa (HS), also known as "acne inversa," is a chronic dermatologic disease affecting apocrine gland-bearing areas and presenting with symptoms ranging from pustules and inflammatory nodules to draining sinuses, abscesses, and fistulae. The pain and odorous lesions associated with HS contribute to its heightened impact on quality of life in comparison to other diseases; it has been described as "one of the most distressing conditions observed in dermatology." Though it is clear that HS has a significant impact on quality of life, how this manifests remains poorly characterized. The aim of this study is to characterize the quality of life impact of HS and to validate a tool for patients to self-assess the severity of their condition.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 22, 2025
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 14, 2018
Actual (reported)June 18, 2018
Actual (reported)June 28, 2018
Actual (reported)June 30, 2020
Actual (reported)January 22, 2025
Actual (reported)Comparison of self-assessed severity to physician-assessed severity of HS
Participants will be administered a 2-page survey with photographs of HS in varying degrees of severity (Hidradenitis Suppurativa Self-Assessment tool, or HSSA) and asked to check the photo(s) that represent their condition now and when it was the worst it has ever been. The photos correspond with severity levels 0 (no disease), 1, 2, and 3 according to the Hurley Staging system (a commonly used system to evaluate severity of HS). Physicians will also assess the Hurley severity of disease when they see the patient. Agreement between physician severity assessment and self assessment will be measured.
1 day
Test-retest reliability of self-assessed severity of HS
Participants will be administered a 2-page survey with photographs of HS in varying degrees of severity and asked to check the photo(s) that represent their condition now and when it was the worst it has ever been. The photos correspond with severity levels 0 (no disease), 1, 2, and 3 according to the Hurley Staging system (a commonly used system to evaluate severity of HS). At least 30 minutes later, participant's will re-do the HSSA. Agreement between the original and second response will be assessed to establish test-retest reliability of the tool.
1 day
Ability of HSSA to detect changes in disease severity over time
For those patients who are recruited in person, when they come back to the clinic for follow-up, the HSSA will be administered again. The physician will also provide an assessment of severity. These will be compared to the original physician assessment and HSSA result to determine the ability of the HSSA to detect changes in disease severity over time.
1 day
Quality of life as measured by DLQI
1 day
Quality of life as measured by HiSQoL
1 day
Quality of life as measured by RAND-36
1 day
Depression as measured by PHQ-9
1 day
Fear of Negative Evaluation
1 day
The set of all Hidradenitis Suppurativa patients (ICD-10 code: L73.2) who visited Wake Forest Baptist Medical Center's dermatology clinic during the last 5 years will either be recruited in person or be mailed the HS Severity Self-Assessment tool and a survey about their demographics, symptoms, treatments, psychological aspects, and lifestyle.
Subset of all Hidradenitis Suppurativa patients who visited the Wake Forest Baptist Medical Center's dermatology clinic during last 5 years will be mailed questionnaires and recruited in clinic.
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27517, United States
Ball SL, Tidman MJ. Managing patients with hidradenitis suppurativa. Practitioner. 2016 May;260(1793):25-9, 3.
Wolkenstein P, Loundou A, Barrau K, Auquier P, Revuz J; Quality of Life Group of the French Society of Dermatology. Quality of life impairment in hidradenitis suppurativa: a study of 61 cases. J Am Acad Dermatol. 2007 Apr;56(4):621-3. doi: 10.1016/j.jaad.2006.08.061. Epub 2006 Oct 20.
Steven R. Feldman, M.D., Ph.D.
Wake Forest University Health Sciences
67 participants (actual enrollment reported by the registry).
First Submitted
June 18, 2018
First Posted
June 28, 2018
Study Start
May 14, 2018
Actual (reported)Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
Contact the study team to confirm eligibility.
Alavi A, Anooshirvani N, Kim WB, Coutts P, Sibbald RG. Quality-of-life impairment in patients with hidradenitis suppurativa: a Canadian study. Am J Clin Dermatol. 2015 Feb;16(1):61-5. doi: 10.1007/s40257-014-0105-5.
Primary Completion
June 30, 2020
Actual (reported)Study Completion
January 22, 2025
Actual (reported)Last Updated
November 26, 2025
Record last verified: 2025-11
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Source: ClinicalTrials.gov.
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