Hidradenitis SuppurativaNCT03572738
Hidradenitis Suppurativa Mail Survey
An observational study of Hidradenitis Suppurativa, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hidradenitis Suppurativa
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2018to 22 Jan 2025
- 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 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients diagnosed with Hidradenitis Suppurativa by a dermatologist at Wake Forest Baptist Medical Center's dermatology clinic.
- Patients 18 years of age or older
Who cannot join
- Patients younger than 18 years of age
- Any patient who does not have a mailing address on file
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27517
About this study
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.
Read the 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.
- Conditions
- Hidradenitis Suppurativa
- Keywords
- acne inversa, HS, Verneuil's Disease
- 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 |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 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.
Measured: 1 day
Secondary outcomes (7)
Quality of life as measured by DLQI
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Dermatology Life Quality Index (Finlay and Khan) is one of these metrics; it is a standardized questionnaire assessing a patient's quality of life. This will be scored according to standard guidelines and assessed in all subjects. The scores range from 0 to 30, with a higher score indicating higher quality of life impairment. Further analysis may be done to group quality of life by severity and baseline characteristics.
Measured: 1 day
Quality of life as measured by HiSQoL
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Hidradenitis Suppurativa Quality of Life survey (McLellan, Sisic, Oon, Tan) is one of these metrics; it is a standardized questionnaire assessing a patient's quality of life. This will be scored according to standard guidelines and assessed in all subjects. Each factor is rated on a scale from 0-4, 0 meaning HS does not influence that factor at all, and 4 meaning the factor is affected greatly by HS. Thus, higher numbers correlate with higher quality of life impact. Further analysis may be done to group quality of life by severity and baseline characteristics.
Measured: 1 day
Quality of life as measured by RAND-36
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The RAND-36 is one of these metrics; it is a standardized questionnaire assessing a patient's quality of life. This will be scored according to standard guidelines and assessed in all subjects. In terms of scoring, questions are grouped into broader categories: physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional well-being, social functioning, pain, general health, and health change. Each group is assigned a percentage based on responses (0-100), and a higher percentage signifies better quality of life for each category (the greatest is 100%). Further analysis may be done to group quality of life by severity and baseline characteristics.
Measured: 1 day
Depression as measured by PHQ-9
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The PHQ-9 is one of these metrics; it is a standardized questionnaire assessing severity of depression. This will be scored according to standard guidelines and assessed in all subjects. For each of the 9 questions, scores can range from 0-3, 3 being the worst (experiencing the symptom nearly every day). These numbers are summed. A score of 0-4 signifies no depression, 5-9 signifies mild depression, 10-14 signifies moderate depression, 15-19 signifies moderately severe depression, and 20-27 signifies severe depression. Further analysis may be done to group depression status by severity of HS and baseline characteristics.
Measured: 1 day
Fear of Negative Evaluation
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Brief Fear of Negative Evaluation survey (Leary) is one of these metrics; it is a standardized questionnaire assessing social anxiety. This will be scored according to standard guidelines and assessed in all subjects. The score for each question ranges from 0-5, and 4/12 items are reverse coded. Higher scores indicated higher levels of social anxiety. Further analysis may be done to group scores by severity and baseline characteristics.
Measured: 1 day
Emotional Stability as measured by PANAS (Positive and Negative Affect Schedule)
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The PANAS is one of these metrics; it is a standardized questionnaire assessing levels of positive and negative affect. This will be scored according to standard guidelines and assessed in all subjects. The PANAS consists of 20 questions. 10 questions measure positive affect, with scores ranging from 10-50 and higher scores indicating greater positive affect. Similarly, 10 questions measure negative affect, with scores ranging from 10-50, with smaller scores indicating lower levels of negative affect. Further analysis may be done to group scores by severity and baseline characteristics.
Measured: 1 day
Stigmatization as measured by an adaptation of Ginsburg and Link Feelings of Stigmatization
Patients will be administered a survey either in clinic or by mail that includes several baseline characteristics and metrics. The Feelings of Stigmatization survey (adapted from Ginsburg and Link) is one of these metrics; it is a standardized questionnaire assessing stigma associated with disease. This will be scored according to standard guidelines and assessed in all subjects. The adapted survey contains 31 questions asking about stigmatization. Aside from the reverse coded questions, higher scores indicate greater levels of stigmatization (for each question, the score ranges from strongly agree to strongly disagree). Further analysis may be done to group scores by severity and baseline characteristics.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start14 May 2018
- Primary completion30 Jun 2020
- Study completion22 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis SuppurativaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R. Feldman, M.D., Ph.D., Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572738
- Sponsor's protocol ID
- IRB00049730
- Status last verified
- Nov 2025
- First submitted
- 18 Jun 2018
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ball SL, Tidman MJ. Managing patients with hidradenitis suppurativa. Practitioner. 2016 May;260(1793):25-9, 3.
PubMed 27382916Wolkenstein 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.
PubMed 17097366Alavi 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.
PubMed 25432664
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hidradenitis Suppurativa Mail Survey
- ClinicalTrials.gov ID
- NCT03572738
- Acronym / sponsor ID
- IRB00049730
- Conditions
- Hidradenitis Suppurativa
- Keywords
- acne inversa, HS, Verneuil's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 22 Jan 2025 (actual)
- First posted
- 28 Jun 2018 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients diagnosed with Hidradenitis Suppurativa by a dermatologist at Wake Forest Baptist Medical Center's dermatology clinic.
- Patients 18 years of age or older
Key exclusion criteria (2 listed)
- Patients younger than 18 years of age
- Any patient who does not have a mailing address on file
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
Comparison of self-assessed severity to physician-assessed severity of HS
Time frame: 1 day
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.
Test-retest reliability of self-assessed severity of HS
Time frame: 1 day
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.
Ability of HSSA to detect changes in disease severity over time
Time frame: 1 day
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.
7 secondary outcomes
Quality of life as measured by DLQI
Time frame: 1 day
Quality of life as measured by HiSQoL
Time frame: 1 day
Quality of life as measured by RAND-36
Time frame: 1 day
Depression as measured by PHQ-9
Time frame: 1 day
Fear of Negative Evaluation
Time frame: 1 day
Emotional Stability as measured by PANAS (Positive and Negative Affect Schedule)
Time frame: 1 day
Stigmatization as measured by an adaptation of Ginsburg and Link Feelings of Stigmatization
Time frame: 1 day
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 26 Nov 2025.
- Background: PubMed 27382916Ball SL, Tidman MJ. Managing patients with hidradenitis suppurativa. Practitioner. 2016 May;260(1793):25-9, 3.
- Background: PubMed 17097366Wolkenstein 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.
- Background: PubMed 25432664Alavi 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.
- Individual participant dataSharing planned: No
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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. Feldman, M.D., Ph.D. principal investigator
Wake Forest University Health Sciences
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 Wake Forest University Health Sciences 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 2 inclusion and 2 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 26 Nov 2025. 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?
Comparison of self-assessed severity to physician-assessed severity of HS (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03572738, which also lists 3 linked publications.
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 26 Nov 2025.