Clinical trial NCT03572738: Hidradenitis Suppurativa Mail Survey
Official title: Hidradenitis Suppurativa Mail Survey
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hidradenitis Suppurativa
Keywords: acne inversa
HS
Verneuil's Disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-06-28
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: Running a comprehensive study and asking patients what challenges they encounter in their daily lives can shed light on the ways in which HS causes quality of life impairment. In this study, the study team aims to identify the following: problems faced by patients with HS, the rate of depression, the rate of stigmatization, the rate of fear of being accepted in society, treatments that patients have tried (and which treatments seem to have worked best), the rate of alternative treatment use, and the correlation of these factors with the severity of disease.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Comparison of self-assessed severity to physician-assessed severity of HS
timeFrame: 1 day
measure: Test-retest reliability of self-assessed severity of HS
timeFrame: 1 day
measure: Ability of HSSA to detect changes in disease severity over time
timeFrame: 1 day
Secondary outcomes:
measure: Quality of life as measured by DLQI
timeFrame: 1 day
measure: Quality of life as measured by HiSQoL
timeFrame: 1 day
measure: Quality of life as measured by RAND-36
timeFrame: 1 day
measure: Depression as measured by PHQ-9
timeFrame: 1 day
measure: Fear of Negative Evaluation
timeFrame: 1 day
measure: Emotional Stability as measured by PANAS (Positive and Negative Affect Schedule)
timeFrame: 1 day
measure: Stigmatization as measured by an adaptation of Ginsburg and Link Feelings of Stigmatization
timeFrame: 1 day
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R. Feldman, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ball SL, Tidman MJ. Managing patients with hidradenitis suppurativa. Practitioner. 2016 May;260(1793):25-9, 3.
citation: 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.
citation: 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.