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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03572738
Other study ID # IRB00049730
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 14, 2018
Est. completion date November 2024

Study information

Verified date November 2023
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 67
Est. completion date November 2024
Est. primary completion date June 30, 2020
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
Secondary 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. 1 day
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