Hidradenitis Suppurativa Mail Survey

NCT03572738 | Completed

• 1 other identifier: IRB00049730
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hidradenitis Suppurativa

Keywords

acne inversa; HS; Verneuil's Disease

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• 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

Study Arms (1)

Patients with HS

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Patients diagnosed with Hidradenitis Suppurativa by a dermatologist at Wake Forest Baptist Medical Center's dermatology clinic.
• Patients 18 years of age or older

You may not qualify if:

• Patients younger than 18 years of age
• Any patient who does not have a mailing address on file

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27517, United States

Location

Related Publications (3)

• Ball SL, Tidman MJ. Managing patients with hidradenitis suppurativa. Practitioner. 2016 May;260(1793):25-9, 3.

  PMID: 27382916 BACKGROUND

• 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.

  PMID: 17097366 BACKGROUND

• 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.

  PMID: 25432664 BACKGROUND

MeSH Terms

Conditions

Hidradenitis Suppurativa

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Study Officials

• Steven R. Feldman, M.D., Ph.D.

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 28, 2018
• Study Start: May 14, 2018
• Primary Completion: June 30, 2020
• Study Completion: January 22, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)