Clinical trial NCT03275870
Conditions: Hidradenitis Suppurativa Hidradenitis Acne Inversa Boils Follicular Occlusion Triad Follicular Occlusion Tetrad
Sponsor: Elena Gonzalez Brant, MD
Start date: 2017-09-28; Completion date: 2019-06-30
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Hidradenitis suppurativa (HS) is an under-recognized and debilitating disease. Patients suffer from recurring painful abscesses and scarring in their armpits, under the breasts, groin and other areas of the body. The cause of the disease is still unknown and common treatments are only sometimes effective. Overactivity of the immune system has been associated with HS and molecules that cause inflammation have been found in the skin from people with HS. Current therapies have long-term risks including antibiotic resistance and the investigators aim to find new safe and effective therapies for HS.

Hydroxychloroquine is a medication that has been used safely in other diseases for many years. The investigators believe that hydroxychloroquine has the potential to improve HS through multiple mechanisms. Patients enrolled in this study will be treated with hydroxychloroquine for 6 months. The investigators also aim to look at the blood of patients with HS to look for inflammatory molecules that we could possibly target for the treatment of HS. Blood samples will be taken at baseline and following 6 months of treatment.

Detailed description:
Hidradenitis suppurativa is a debilitating and mutilating disease and its pathogenesis is still poorly understood. It involves the development of recurrent, painful nodules in intertriginous areas that become inflamed, form abscesses that may rupture, and develop chronic fistula tracts. The cause of hidradenitis suppurativa (HS) is thought to be multifactorial and may begin with follicular occlusion and rupture, leading to a cascade of inflammatory responses in susceptible individuals. The disease has been associated with high body mass index, smoking and genetic predisposition. There is a known association between HS and the metabolic syndrome, an association that remains after controlling for body mass index. HS predominantly affects women and ethnic minorities and the prevalence is thought to be as high as 2%, although embarrassment and lack of awareness may lead to an underestimate of the true burden of disease.

Although HS is a fairly common disease, relatively little is understood about its pathogenesis. Immune dysregulation is thought to play a role in disease development. Increased levels of interleukin (IL)-12, IL-17, IL-23, tumor necrosis factor α, IL-10 and IL-1β were found to be expressed in lesional skin of HS patients. Recent studies have also identified elevated levels of IL-17 in the serum of patients with HS.

HS is associated with a significant impact on patient quality of life. Patients suffer from both the physical and psychological impact of disease. Many therapies have been used to treat HS, from topical antibiotics to oral retinoids to radical surgeries, but all have limited efficacy. Despite efforts to control disease, many patients live with chronic wounds and disability. The decision about appropriate therapy for HS, especially in the early stages, is mainly based on expert opinion, anecdotal evidence, and small studies. Topical and systemic antimicrobial treatments are often used as first line therapies, although studies have repeatedly shown that the abscesses of HS are sterile or contain only normal flora. The mechanism of improvement with antimicrobials may be through alterations in the local microbiome. Significant improvement in disease has been seen with dual therapy with twice daily use of 300mg rifampicin and 300mg clindamycin, neither of which have an FDA indication for use in HS. Doxycycline is used frequently in HS, but little evidence supports this. Despite success with the above therapies, the risk of antimicrobial resistance is real, and is increased with frequent and prolonged use of these medications in HS. Teratogenic effects, gastrointestinal upset, and photosensitivity with use of tetracyclines, risk for clostridium difficile colitis with clindamycin, and antimicrobial resistance with rifampicin highlight a need for safer and effective therapeutic options for the treatment of early HS.

For more advanced disease (Hurley stage II and III), the tumor necrosis factor inhibitor adalimumab is the only FDA approved biologic treatment for HS. It has shown promise in severe disease, but only \~50% of patients achieved a clinical response at 12 weeks, and this clinical response declined over time. Additionally, newer biologic therapies have been used in small numbers of patients with HS with variable results. Importantly, the cost of these medications is considerable.

Hydroxychloroquine, initially developed as an antimalarial, has been used successfully for over 70 years in the treatment of autoimmune disease. Its mechanism of action is still poorly understood, but it has been shown to have many varied immunomodulatory properties. Evidence suggests that hydroxychloroquine has an effect on inflammatory disease through decreasing levels of TNFα and Th-17 cytokines (including IL-6, IL-17, and IL-22). Additionally, studies have shown a beneficial effect of hydroxychloroquine on lipid metabolism and glucose. Patients with rheumatoid arthritis (which similarly to HS has an independent association with cardiovascular disease) who were treated with hydroxychloroquine had an overall decreased incidence of cardiovascular events. Hydroxychloroquine has a relatively benign safety profile, with retinopathy being the most concerning long term side effect. The retinopathy caused by hydroxychloroquine is reversible if identified early, and standard protocols for the use of this medication include yearly ophthalmologic examination.

Patients with HS suffer daily from the physical and psychological effects of their disease. Despite insufficient data about disease progression and prognosis, early intervention with safe and effective therapies is our goal. Hydroxychloroquine has never been used to treat HS, but the good safety profile, based on many years of usage in other autoimmune diseases, and known ability to modify many of the aberrant metabolic and inflammatory components of HS make it an ideal candidate therapy for this debilitating disease.

Research activities:

1. Treatment with hydroxychloroquine 200mg twice daily. Treatment length will be 6 months. Patients will be allowed to continue or initiate use of topical therapies during the study.
2. Telephone call to assess toxicity after 1 month of treatment
3. Assessment of hidradenitis suppurativa disease activity using Sartorius scoring at baseline, and after 3 and 6 months of treatment
4. Collection of patient serum at baseline and after 6 months of treatment
5. Quality of life questionnaire at baseline, 3 and 6 months
6. Follow up telephone call at \~9 and 12 months (3 and 6 months after therapy completion) to assess for toxicity
7. Baseline ophthalmologic exam for patients on hydroxychloroquine will be conducted within the first year of treatment

Arms: arm 1: Hydroxychloroquine 200mg BID for 6 months
Interventions: intervention 1: Hydroxychloroquine
Intervention descriptions: intervention 1: Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months

Protocol documents:
Prot_SAP_003.pdf: 
Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa 
NCT #:03275870
 06/03/2019
                                                                           Page 1 of 9                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


1.0 Specific Aims
To evaluate the efficacy of hydroxychloroquine as a treatment for hidradenitis suppurativa (HS)
We will conduct a pilot trial of standard dosing of hydroxychloroquine in patients with HS
To identify biomarkers as possible therapeutic targets for the treatment of HS
We will evaluate the levels of inflammatory cytokines in the peripheral blood of patients with HS.
2.0 Background information
Hidradenitis suppurativa is a debilitating and mutilating disease and its pathogenesis is still 
poorly understood. It involves the development of recurrent, painful nodules in intertriginous 
areas that become inflamed, form abscesses that may rupture, and develop chronic fistula 
tracts. The cause of hidradenitis suppurativa (HS) is thought to be multifactorial and may begin 
with follicular occlusion and rupture, leading to a cascade of inflammatory responses in 
susceptible individuals. The disease has been associated with high body mass index, smoking 
and genetic predisposition. There is a known association between HS and the metabolic 
syndrome, an association that remains after controlling for body mass index 1 . HS 
predominantly affects women and ethnic minorities  2, 3 and the prevalence is thought to be as 
high as 2%, although embarrassment and lack of awareness may lead to an underestimate of 
the true burden of disease. 
Although HS is a fairly common disease, relatively little is understood about its pathogenesis. 
Immune dysregulation is thought to play a role in disease development. Increased levels of IL-
12, IL-17 and IL-23, TNFα, IL-10 and IL-1β were found to be expressed in lesional skin of HS 
patients 4, 5. Recent studies have also identified elevated levels of IL-17 in the serum of patients 
with HS 6 . 
HS is associated with a significant impact on patient quality of life  7 . Patients suffer from both 
the physical and psychological impact of disease. Many therapies have been used to treat HS, 
from topical antibiotics to oral retinoids to radical surgeries, but all have limited efficacy. Despite 
efforts to control disease, many patients live with chronic wounds and disability. The decision 
about appropriate therapy for HS, especially in the early stages, is mainly based on expert 
opinion, anecdotal evidence and small studies. Topical and systemic antimicrobial treatments 
are often used as first line therapies, although studies have repeatedly shown that the 
abscesses of HS are sterile or contain only normal flora. The mechanism of improvement with 
antimicrobials may be through alterations in the local microbiome. Significant improvement in 
disease has been seen with dual therapy with twice daily use of 300mg rifampicin and 300mg 
clindamycin 8, neither of which have an FDA indication for use in HS. Doxycycline is used 
frequently in HS, but little evidence supports this. Despite success with the above therapies, the 
risk of antimicrobial resistance is real, and is increased with frequent and prolonged use of 
these medications in HS 9 . Teratogenic effects, gastrointestinal upset and photosensitivity with 
use of tetracyclines, risk for clostridium difficile colitis with clindamycin, and antimicrobial 
resistance with rifampicin highlight a need for safer and effective therapeutic options for the 
treatment of early HS. 
For more advanced disease (Hurley stage II and III), the tumor necrosis factor inhibitor 
adalimumab is the only FDA approved biologic treatment for HS. It has shown promise in 
severe disease, but only ~50% of patients achieved a clinical response at 12 weeks, and this 
clinical response declined over time 10 . Additionally, newer biologic therapies have been used in 
small numbers of patients with HS with variable results. Importantly, the cost of these 
                                                                           Page 2 of 9                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


medications is considerable.
Hydroxychloroquine, initially developed as an antimalarial, has been used successfully for over 
70 years in the treatment of autoimmune disease. Its mechanism of action is still poorly 
understood, but it has been shown to have many varied immunomodulatory properties  11 . 
Evidence suggests that hydroxychloroquine has an effect on inflammatory disease through 
decreasing levels of TNFα 12 and Th-17 cytokines (including IL-6, IL-17 and IL-22)13 . Additionally,
studies have shown a beneficial effect of hydroxychloroquine on lipid metabolism and glucose 
14 . Patients with rheumatoid arthritis (which similarly to HS has an independent association with 
cardiovascular disease) who were treated with hydroxychloroquine had an overall decreased 
incidence of cardiovascular events 15 . Hydroxychloroquine has a relatively benign safety profile, 
with retinopathy being the most concerning long term side effect. The retinopathy caused by 
hydroxychloroquine is reversible if identified early, and standard protocols for the use of this 
medication include yearly ophthalmologic examination.
3.0 Experimental Design and Methods
We hypothesize that treatment with hydroxychloroquine may offer a safer and effective method 
to control disease activity in HS. We hypothesize that the profiling inflammatory cytokines in the 
peripheral blood of the patients with HS may provide novel therapeutic targets for the disease. 
Additionally, monitoring of inflammatory cytokines before and after treatment may help to 
explain the mechanism by which therapies work.  Over the proposed period, we intend to gather
data about patient response to treatment with hydroxychloroquine and about the cytokine profile
of patients with HS. Sequential patients will be assigned to hydroxychloroquine treatment. 
Patients will be evaluated at baseline and after 3 months of treatment for treatment response 
and to evaluate quality of life measures. Serum will be collected at baseline and following 3 
months of treatment. Peripheral blood from patients with HS will be analyzed for levels of 
cytokines thought to be involved in HS and several markers of inflammation that have not yet 
been analyzed in this disease. 
Treatment
Patients will have baseline CBC and CMP evaluation prior to initiation of therapy
Sequential patients will be assigned treatment with hydroxychloroquine 200mg BID
Treatment length will be 3 months
Evaluation of HS
Patients will be evaluated at baseline and at 3 months by:
Hurley staging: 
Stage 1: solitary or multiple, isolated abscess formation without scarring or sinus 
tracts
Stage 2: recurrent abscesses, single or multiple widely separated lesions, with 
sinus tract formation
Stage 3: diffuse or broad involvement, with multiple interconnected sinus tracts 
and abscesses
Number of inflammatory nodules, abscesses, fistulas, scars, locations of these lesions, longest 
distance between 2 relevant lesions, are lesions separated by normal skin (for 
Sartorius scoring)
Improvement in HS lesions
Sartorius score: A statistically significant decline in Sartorius scoring between baseline and end 
of treatment
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   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


Evaluation of quality of life
Patients will be asked to fill out Dermatology Life Quality Index  (DLQI) survey at baseline and 3 
months. It is a simple, validated 10-question questionnaire. Answers to the 
questionnaire will be entered into a database.
For general inflammatory skin conditions a change in DLQI score of at least 4 points is 
considered clinically important
Serum for evaluation
Peripheral blood will be collected at baseline and after 3 months of treatment. A 10 ml red top 
tube of venous blood will be obtained from patients at the time of enrollment and at 
month 3 for banking and cytokine analysis. The red top tubes will be centrifuged, 
sera will be aliquoted, logged in the database and stored indefinitely at -800C without 
identifiers by a technician in Dr. Akilov's laboratory.
Cytokine analysis
Using an inflammatory cytokine panel, levels of cytokines including L-1β, IL-4, IL-6, IL-10, IL-
17A, IL-17F, L-21, IL-22, IL-23, IL-25, IL-31, IL-33, IFN-γ, sCD40L and TNF-α will
be evaluated at baseline and 3 months. Analysis will be performed at the 
University of Pittsburgh Cancer Institute Luminex core facility using multianalyte 
profiling. Levels will be compared to age, sex and BMI matched controls in our 
database.
Therapy may be discontinued for any of the following reasons:
Unacceptable adverse event(s),
Patient decides to withdraw from the study, or
General or specific changes in the patient’s condition render the patient unacceptable for further
treatment in the judgment of the investigator.
4.0 Human Subjects
Protection of Human Subjects
Human Subjects Involvement, Characteristics, and Design. The racial, gender and ethnic 
characteristics of the proposed subject population will reflect the demographics of 
Pittsburgh and the surrounding area and/or the patient population of the UPMC 
Health Systems.  We shall attempt to recruit subjects in respective proportions to 
these demographics. No exclusion criteria will be based on race, ethnicity, gender, or
socioeconomic status. The numbers of enrolled male to female subjects will be 
consistent with and reflective of the numbers of patients seen in the UPMCHS clinics
and in approximate 1:1 proportion. 
Sources of material. 
Information on the subject's medical history will be obtained relative to the inclusion and 
exclusion criteria. Data collection methods will include data obtained specifically for 
research purposes based on the most recent office note. All records related to this 
research study will be stored in a locked file cabinet. The subject’s identity on these 
records will be indicated by a case number rather than by name, and the information 
linking these case numbers will be kept separate from the research records.
Recruitment
Potential subjects with Hurley stage I/II hidradenitis suppurativa will be identified by the 
                                                                           Page 4 of 9                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


examining physician and referred for evaluation by the principal investigator or co-
investigator.  Subjects will be recruited from the UPMC dermatology department 
clinics. Potential subjects will be evaluated by the Principal Investigator, who is also 
the treating physician, during a routine clinic visit prior to any screening procedures 
or evaluation of the medical record for research purposes.  Potential subjects will be 
approached by physicians directly involved in their care.  No “cold calling” will occur. 
Informed consent will be obtained on all subjects by the principal investigator prior to 
all screening procedures.  If for any reason, a subject is excluded or resigns during 
the course of study, a new subject will be enrolled. 
Inclusion Criteria
Enrolled HS patients must be Hurley stage I or II (defined above)
Patients may be on topical therapy only, and/or have completed non-immunosuppressive 
therapy at time of enrollment.
Subjects must be 18 years of age and must be able to understand the written informed consent.
No evidence of active infection, regardless of the degree of severity or localization.  Subjects 
with active infections (whether or not they require antibiotic therapy) may be eligible 
after complete resolution of the infection. Subjects on antibiotic therapy must be off 
antibiotics for at least 7 days before beginning treatment.
Exclusion criteria
Subjects currently on systemic immunosuppression are ineligible
Subjects under 18 years of age
Due to small risk of retinopathy, hepatic disease, psoriasis exacerbation, exacerbation of 
porphyria cutanea tarda (PCT) in patients treated with hydroxychloroquine, subjects 
with known retinal disease, hepatic disease, psoriasis and PCT will be excluded
Due to potential fetal risk with use of hydroxychloroquine, pregnant patients or those planning to
become pregnant will be excluded
Risks to the subjects:
i.
The risks of the study are minimal and are related drug therapy and to obtaining the 
blood samples needed for our analysis. 
1.
Physical. 
a)
Small likelihood of drug toxicity. Hydroxychloroquine has been used for many 
years and is known to have a mild side effect profile. 
b)
Small likelihood of infection or bleeding. Risks minimized by proper protective 
equipment and hygiene
2.
Psychological. There is a small likelihood of low psychological risk if participants are 
upset by request to be involved in the study
7.
Benefits
i.
Benefits may accrue to patients with HS. Benefits may accrue to study subjects who 
participate through greater awareness leading to greater individual and community 
empowerment, enhanced knowledge of community assets as well as health 
concerns and needs, and enhanced skills related to performance of duties as study 
subjects. Outside of participants in research, all community members may also 
benefit from enhanced trust and reciprocity within the community. 
5.0 Statistical considerations
                                                                           Page 5 of 9                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


1. Sample size
i.
The study will involve 20 patients with hidradenitis suppurativa
ii.
The comparison of baseline Sartorius scores and level of the measured cytokines in 
peripheral blood from HS will be compared using a two-sided t test with a p value 
<0.05 for statistical significance.
iii.
The probability is 80% that the study will detect a difference at a two-sided 0.05 
significance level if the true difference between groups is 30%.
6.0 Adverse Reaction Reporting Requirements:
This study will use the CTC version 2.0 for toxicity and Adverse Event reporting. A copy of the 
CTC version 2.0 can be downloaded from the CTEP home page (http://ctep.info.nih.gov). All 
appropriate treatment areas should have access to a copy of the CTC version 2.0.  All Serious 
Adverse events that require reporting to the FDA will be reported on the FDA 3500 medwatch 
form found in Appendix B
i.
The following adverse reactions must be reported in the manner described below. 
ii.
All adverse events which are considered to be related to the research study must be reported to
the University of Pittsburgh Cancer Institute (UPCI)
iii.
All serious adverse events that meet the University of Pittsburgh Institutional Review Board’s 
criteria for reporting can be found at (http://irb.pitt.edu)
Unexpected, 
fatal or life 
threatening and
associated with 
study drug
Unexpected, of 
moderate or 
greater severity
(But not fatal or 
life threatening)
and are 
associated with 
the research 
intervention
Serious, 
unexpected 
event that is 
associated with 
the study drug
Unexpected 
fatal
or life-
threatening
experience 
which is 
associated with 
the study drug
Call to UPCI 
within 24 hours 
at (412) 647-
8074
              X
  
Notify IRB within 
24 hours
              X
Notify UPCI as 
soon as 
               X
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   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


possible & local 
IRB within 10 
days
FDA notification 
within 15 days
               X
FDA notification 
within 7 days
                X
An adverse reaction is considered serious if it is fatal or life-threatening; requires or 
prolongs hospitalization; produces a disability; or results in a congenital anomaly/birth 
defect.
An adverse reaction is considered to be of moderate or greater severity if it requires 
medical evaluation (such as additional laboratory testing) and/or medical treatment; or if 
it is a serious adverse reaction.
An adverse reaction is considered to be unexpected if it is not identified in nature, 
severity or frequency in the current IRB-approved research protocol or informed consent 
document.
An adverse reaction is considered to be associated with the research intervention if 
there is a reasonable possibility that the reaction may have been caused by the research
intervention (i.e., a causal relationship between the reaction and research intervention 
cannot be ruled out by the investigators).
UPCI requires ADRs to be reported on the Medwatch form and on the University of 
Pittsburgh IRB adverse event form. The University of Pittsburgh Adverse event form 
must be signed by the treating investigator. 
(See Appendix A for copies of the Adverse event reporting forms).
 
iv.
FDA Guidelines for Adverse Event Reporting
All adverse events meeting the definition of serious, unexpected and associated to the 
research intervention will be reported to the IRB according to their guidelines found at 
(http://irb.pitt.edu):
Associated with the use of the drug. There is a reasonable possibility that the experience
may have been caused by the drug. 
Disability:  A substantial disruption of a person's ability to conduct normal life functions. 
Life threatening adverse drug experience. Any adverse drug experience that places the 
patient or subject, in the view of the investigator, at immediate risk of death from the 
reaction as it occurred, i.e., it does not include a reaction that, had it occurred in a more 
severe form, might have caused death. 
                                                                           Page 7 of 9                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


Serious adverse drug experience: Any adverse drug experience occurring at any dose 
that results in any of the following outcomes: death, a life threatening adverse drug 
experience, inpatient hospitalization or prolongation of existing hospitalization, a 
persistent or significant disability/ incapacity, or a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life threatening, or require 
hospitalization may be considered a serious adverse drug experience when, based upon
appropriate medical judgment, they may jeopardize the patient or subject and may 
require medical or surgical intervention to prevent one of the outcomes listed in this 
definition
Unexpected adverse drug experience: Any adverse drug experience, the specificity or 
severity of which is not consistent with the current investigator brochure; or, if an 
investigator brochure is not required or available, the specificity or severity of which is 
not consistent with the risk information described in the general investigational plan or 
elsewhere in the current application, as amended. "Unexpected," as used in this 
definition, refers to an adverse drug experience that has not been previously observed 
(e.g., included in the investigator brochure) rather than from the perspective of such 
experience not being anticipated from the pharmacological properties of the 
pharmaceutical product. 
7.0 Reporting of results
Following acquisition of the descriptive data and the calculation of formal statistics, 
manuscript(s) will be prepared for submission to peer reviewed journals.
8.0 Costs and Payments
Neither subject, nor their insurance provider, will be charged for the costs of any of the 
procedures performed for the sole purpose of this research study (i.e., the Screening 
Procedures, Experimental Procedures, or Monitoring Procedures described above). Subjects 
will be charged, in the standard manner, for any procedures performed for their routine medical 
care.
References
1. Gonzalez-Lopez MA, Hernandez JL, Lacalle M, Mata C, Lopez-Escobar M, Lopez-Mejias R, 
et al. Increased prevalence of subclinical atherosclerosis in patients with hidradenitis 
suppurativa (HS). J Am Acad Dermatol. 2016 Aug;75(2):329-35.
2. Nicola WG, Khayria MI, Osfor MM. Plasma testosterone level and the male genital system 
after chloroquine therapy. Boll Chim Farm. 1997 Jan;136(1):39-43.
3. Garg A, Lavian J, Lin G, Strunk A, Alloo A. Incidence of hidradenitis suppurativa in the united 
states: A sex- and age-adjusted population analysis. J Am Acad Dermatol. 2017 Mar 9.
4. Schlapbach C, Hanni T, Yawalkar N, Hunger RE. Expression of the IL-23/Th17 pathway in 
lesions of hidradenitis suppurativa. J Am Acad Dermatol. 2011 Oct;65(4):790-8.
5. van der Zee HH, de Ruiter L, van den Broecke DG, Dik WA, Laman JD, Prens EP. Elevated 
levels of tumour necrosis factor (TNF)-alpha, interleukin (IL)-1beta and IL-10 in hidradenitis 
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   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


suppurativa skin: A rationale for targeting TNF-alpha and IL-1beta. Br J Dermatol. 2011 
Jun;164(6):1292-8.
6. Matusiak L, Szczech J, Bieniek A, Nowicka-Suszko D, Szepietowski JC. Increased interleukin
(IL)-17 serum levels in patients with hidradenitis suppurativa: Implications for treatment with 
anti-IL-17 agents. J Am Acad Dermatol. 2017 Apr;76(4):670-5.
7. von der Werth JM, Jemec GB. Morbidity in patients with hidradenitis suppurativa. Br J 
Dermatol. 2001 Apr;144(4):809-13.
8. Andersen RK, Jemec GB. Treatments for hidradenitis suppurativa. Clin Dermatol. 2017 Mar - 
Apr;35(2):218-24.
9. Fischer AH, Haskin A, Okoye GA. Patterns of antimicrobial resistance in lesions of 
hidradenitis suppurativa. J Am Acad Dermatol. 2017 Feb;76(2):309,313.e2.
10. Kimball AB, Okun MM, Williams DA, Gottlieb AB, Papp KA, Zouboulis CC, et al. Two phase 
3 trials of adalimumab for hidradenitis suppurativa. N Engl J Med. 2016 Aug 4;375(5):422-34.
11. Rainsford KD, Parke AL, Clifford-Rashotte M, Kean WF. Therapy and pharmacological 
properties of hydroxychloroquine and chloroquine in treatment of systemic lupus erythematosus,
rheumatoid arthritis and related diseases. Inflammopharmacology. 2015 Oct;23(5):231-69.
12. van den Borne BE, Dijkmans BA, de Rooij HH, le Cessie S, Verweij CL. Chloroquine and 
hydroxychloroquine equally affect tumor necrosis factor-alpha, interleukin 6, and interferon-
gamma production by peripheral blood mononuclear cells. J Rheumatol. 1997 Jan;24(1):55-60.
13. Silva JC, Mariz HA, Rocha LF,Jr, Oliveira PS, Dantas AT, Duarte AL, et al. 
Hydroxychloroquine decreases Th17-related cytokines in systemic lupus erythematosus and 
rheumatoid arthritis patients. Clinics (Sao Paulo). 2013 Jun;68(6):766-71.
14. Hage MP, Al-Badri MR, Azar ST. A favorable effect of hydroxychloroquine on glucose and 
lipid metabolism beyond its anti-inflammatory role. Ther Adv Endocrinol Metab. 2014 
Aug;5(4):77-85.
15. Sharma TS, Wasko MC, Tang X, Vedamurthy D, Yan X, Cote J, et al. Hydroxychloroquine 
use is associated with decreased incident cardiovascular events in rheumatoid arthritis patients.
J Am Heart Assoc. 2016 Jan 4;5(1):10.1161/JAHA.115.002867.
                                                                           Page 9 of 9                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612

ICF_002.pdf: 
Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa 
NCT #:03275870
 06/03/2019
                                                                           Page 1 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


Consent to Act as a Participant in a Research Study
STUDY TITLE: Pilot Study of Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa
PRINCIPAL INVESTIGATOR: Elena Gonzalez Brant, MD. Phone (412) 647-4200
3708 Fifth Ave.
Medical Arts Building
5th floor suite 500.68
Pittsburgh, PA 15213
QUESTIONS ABOUT THE STUDY:
IYou can contact the study investigator if you have any questions about the study, 
concerns or complaints. Contact Principal Investigator, Dr. Gonzalez Brant at (412) 647-
4200.
INTRODUCTION:
Hidradenitis suppurativa (HS) is an under-recognized and debilitating disease. Patients 
suffer from recurring painful abscesses and scarring in their armpits, under the breasts, 
groin and other areas of the body. The cause of the disease is still unknown and 
common treatments are only sometimes effective. Current therapies have long-term 
risks including antibiotic resistance and we aim to find new safe and effective therapies 
for HS. We believe that hydroxychloroquine has the potential to improve HS through 
multiple mechanisms.
Overactivity of the immune system has been associated with HS and molecules that 
cause inflammation have been found in the skin from people with HS. We aim to look at 
the blood of patients with HS to look for inflammatory molecules that we could possibly 
target for the treatment of HS.
Patients with mild-to-moderate HS are being asked to participate. We hope to find 20 
subjects to be involved in this study.
You will be enrolled in the study for approximately 13 months
PURPOSE OF THE STUDY:
We aim to see if hydroxychloroquine is a safe and reasonable treatment for hidradenitis 
suppurativa. We also want to see if the levels of inflammatory molecules are different in the 
blood of people with HS compared to people without HS.
WHEN THE INVESTIGATOR IS ALSO THE CARE-PROVIDER:
Your physician is involved as an investigator in this research study. Before agreeing to 
participate, or at any time during your study participation, you may discuss your care with
                                                                           Page 2 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


another doctor who is not associated with this research study. You are not under any 
obligation to participate in any research study offered by your physician.
RESEARCH ACTIVITIES:
1.
Screening Procedures
◦
Before you can be enrolled in this study, we will need to do some blood tests to 
make sure your liver function, kidney function and blood counts are within the normal
range
◦
If you are a woman of child-bearing potential we will perform a pregnancy test 
because this medication should not be used during pregnancy
2.
Treatment with hydroxychloroquine
◦
Hydroxychloroquine is an oral medication (pill) that has been used safely to treat a 
variety of diseases since 1955. It is FDA approved for the treatment of lupus, 
rheumatoid arthritis and malaria. Hydroxychloroquine is not FDA approved for the 
treatment of HS.
◦
You will be asked to take a 200mg pill two times a day for 6 months.
◦
It is recommended that you use sunscreen, as this medication can cause 
photosensitivity
◦
You will be evaluated for any side effects with a telephone call after 1 month and at 
your 3 and 6 month follow up visits.
◦
If you experience any side effects while on this medication, you will be instructed to 
contact your doctor to let them know
◦
If you have good results with this treatment, you may be able to continue the 
treatment after the study is completed
◦
You may continue to use medicated washes, creams, ointments and lotions during 
this study
◦
You will be evaluated for any side effects with a telephone call 3 and 6 months after 
your finish your treatment.
◦
You will be asked to have a baseline eye exam within the first year of treatment
3.
Optional collection of blood samples for analysis of markers of inflammation
◦
Inflammation is known to drive HS, but the mechanism it is still not well understood in
this disease. If we can understand more about the inflammatory molecules in HS, we
can potentially identify new treatments.
◦
If you would like to provide a blood sample, a small sample of your blood will be 
taken at the beginning of the study and after you have had 6 months of treatment
◦
Your blood samples will be stored without your name or other identifying information
◦
You may still participate in this study if you choose not to provide blood 
samples
4.
Quality of life questionnaire
                                                                           Page 3 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


◦
You will be asked to complete a short paper questionnaire about your quality of life 
before you start treatment and at your 3 and 6 month follow up appointments. It 
should not take longer than 15 minutes to complete each time.
STUDY RISKS:

The use of hydroxychloroquine has been evaluated in many other diseases and is quite 
safe. Side effects include blurred vision, changes in vision, dizziness, headache, 
abdominal pain, nausea, vomiting, diarrhea, itching, and low appetite. You should not 
take this medication if you are pregnant or are planning to become pregnant. Rare 
side effects include imbalance, hair bleaching, sun sensitivity, ringing in the ears, low 
blood counts, seizures, lip and throat swelling, trouble breathing, skin rashes, worsening 
of psoriasis, worsening of porphyria (a light-sensitive skin condition), eye disease, heart 
disease, liver disease, heart rhythm abnormalities, depression, psychosis, anxiety, 
suicidality, low blood sugar. 

Getting your blood drawn will be no different than you have experienced for other lab 
testing. There is a very low risk of infection at the site of the blood draw. Bruising may 
occur at the site of the blood draw.
STUDY BENEFITS:

Thorough screening and side effect monitoring will be used to minimize risk during 
treatment with hydroxychloroquine. 

Participation in this study may help to improve your HS
ALTERNATIVE TREATMENTS:

Other possible treatment options include medicated washes, antibiotic creams, oral 
antibiotics (including doxycycline, clindamycin and rifampin), acitretin, isotretinoin, 
biologic medications (adalimumab), corticosteroids, hormone manipulation and surgical 
intervention

If you would like to discuss any alternative treatments to this research study, your doctor 
will be available to do so.

If you do not want to participate in the research study, you may still be able to get 
treatment with hydroxychloroquine, if you choose to do so
NEW INFORMATION:
You will be promptly notified if any new information we learn during this research study 
may cause you to change your mind about continuing to participate in the study.
                                                                           Page 4 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


PRIVACY (Person) and CONFIDENTIALITY (Data):

Your identification will be removed from the research data. Linkage code information will 
be stored in a separate locked cabinet

Only the principal investigator (Dr. Gonzalez Brant) and co-investigator (Dr. Akilov) will 
have access to your data

Per University of Pittsburgh policy all research records must be maintained for at least 7 
years following final reporting or publication of a project.
SUBJECT ACCESS TO RESEARCH RESULTS IN MEDICAL RECORDS:

This research study will involve the review of your medical records to confirm your 
eligibility to participate in this study.

You will be provided with the final results of the study once the study has been 
completed (all 20 participants have completed 6 months of treatment). These results will 
be sent to you by mail.
FDA Clinical Trial Registry
A description of this clinical trial will be available on http://www.clinicaltrials.gov, as 
required by US Law. This website will not include information that can identify you. At 
most, the website will include a summary of the results. You can search this website at 
any time.
WITHDRAWAL FROM STUDY PARTICIPATION:
1.
You can, at any time withdraw from this research study; you can also withdraw your 
authorization for us to use your identifiable medical information for the purposes 
described above. This means that you will also be withdrawn from further 
participation in this research study. Any identifiable research or medical information 
obtained as part of this study prior to the date that you withdrew your consent will 
continue to be used and disclosed by the investigators for the purposes described 
above.
2.
To formally withdraw from this research study, you should provide a written and 
dated notice of this decision to the principal investigator of this research study at the 
address listed on the first page of this form. Your decision to withdraw from this study
will have no effect on your current or future relationship with the University of 
Pittsburgh.
3.
Your decision to withdraw your consent for participation in this research study will 
have no effect on your current or future medical care at a UPMC hospital or affiliated 
                                                                           Page 5 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


health care provider or your current or future relationship with a health care 
insurance provider.
4.
Investigator removes subject from study:
1.
It is possible that you may be removed from the research study by the 
researchers if, for example, you are having an adverse reaction to the drug
5.
Investigator may request follow-up for safety reasons: If you are withdrawn from 
participation in this research study, you will asked to continue to follow up to ensure 
resolution of any adverse reaction
COSTS:

The cost of the drug is not covered by the research study and you or your insurer 
will be responsible for covering this cost. The cost of the lab testing will be paid for by 
the research study. You will be charged in the usual manner for any procedures 
performed as part of your standard medical care (care you would receive even if you 
were not participating in this research study).
COMPENSATION FOR INJURY:

If you believe that the research procedures have resulted in an injury to you, immediately
contact the Principal Investigator who is listed on the first page of this form. Emergency 
medical treatment for injuries solely and directly related to your participation in this 
research study will be provided to you by the hospitals of UPMC. Your insurance 
provider may be billed for the costs of this emergency treatment, but none of those costs
will be charged directly to you. If your research-related injury requires medical care 
beyond this emergency treatment, you will be responsible for the costs of this follow-up 
care. At this time, there is no plan for any additional financial compensation. You do not, 
however, waive any legal rights by signing this form.
VOLUNTARY PARTICIPATION:
Your participation in this research study is entirely voluntary. You may want to discuss 
this study with your family and friends and your personal physician before agreeing to 
participate. If there are any words you do not understand, feel free to ask us. The 
investigators will be available to answer your current and future questions.
Whether or not you provide your consent for participation in this research study will have 
no effect on your current or future relationship with the University of Pittsburgh. Whether 
or not you provide your consent for participation in this research study will have no effect
on your current or future medical care at a UPMC hospital or affiliated health care 
provider or your current or future relationship with a health care insurance provider.
                                                                           Page 6 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


As both your doctor and a research investigator, she is interested both in your medical 
care and the conduct of this research study. Before agreeing to participate in this 
research study, or at any time during your study participation, you may discuss your care
with another doctor who is not associated with this research study. You are not under 
any obligation to participate in any research study offered by your doctor.
To formally withdraw your consent for participation in this research study you should 
provide a written and dated notice of this decision to the principal investigator of this 
research study at the address listed on the first page of this form.
****************************************************************************************************
VOLUNTARY CONSENT:
The above information has been explained to me and all of my current questions have been 
answered. I understand that I am encouraged to ask questions, voice concerns or complaints 
about any aspect of this research study during the course of this study, and that such future 
                                                                           Page 7 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612


questions, concerns or complaints will be answered by a qualified individual or by the 
investigator(s) listed on the first page of this consent document at the telephone number(s) 
given.
I understand that I may always request that my questions, concerns or complaints be addressed
by a listed investigator. I understand that I may contact the Human Subjects Protection 
Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss problems, 
concerns, and questions; obtain information; offer input; or discuss situations that occurred 
during my participation. 
By signing this form I agree to participate in this research study and for the use and disclosure 
of my medical record information for the purposes described above.  A copy of this consent form
will be given to me.
__________________________________
Printed name of Participant
__________________________________     
______________   
Signature of Participant
Date
CERTIFICATION OF INFORMED CONSENT
I certify that I have explained the nature and purpose of this research study to the above-named
individual(s), and I have discussed the potential benefits and possible risks of study 
participation. Any questions the individual(s) have about this study have been answered, and 
we will always be available to address future questions, concerns or complaints as they arise. I 
further certify that no research component of this protocol was begun until after this consent 
form was signed.
___________________________________        
_______________________________
Printed Name of Person Obtaining Consent
Role in Research Study
_________________________________
_______________________________
Signature of Person Obtaining Consent
Date 
                                                                           Page 8 of 8                                          
          
   University Of Pittsburgh         
     Institutional Review Board   
Approval Date: 6/3/2019
Renewal Date:  6/2/2020
IRB #:   PRO17030612