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Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03275870
Recruitment Status : Active, not recruiting
First Posted : September 8, 2017
Last Update Posted : April 23, 2019
Information provided by (Responsible Party):
Elena Gonzalez Brant, MD, University of Pittsburgh

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.

Condition or disease Intervention/treatment Phase
Hidradenitis Suppurativa Hidradenitis Acne Inversa Boils Follicular Occlusion Triad Follicular Occlusion Tetrad Drug: Hydroxychloroquine Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa
Actual Study Start Date : September 28, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Hydroxychloroquine treatment
Hydroxychloroquine 200mg BID for 6 months
Drug: Hydroxychloroquine
Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
Other Name: Plaquenil

Primary Outcome Measures :
  1. Improvement in disease severity [ Time Frame: 6 months ]
    Comparison of baseline and post-treatment Sartorius severity scoring

Secondary Outcome Measures :
  1. Improvement in quality of life [ Time Frame: 6 months ]
    Comparison of baseline and post-treatment self-reported quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with hidradenitis suppurativa Hurley stage I or II

Exclusion Criteria:

  • Current systemic immunosuppression, current use of biologic medication or use of these medications in the prior 3 months, patients with known retinal disease, hepatic disease (HCV, cirrhosis, aspartate aminotransferase or alanine aminotransferase > 2 times the upper limit of normal), psoriasis, porphyria cutanea tarda, platelets < 50,000/ul, leukocytes <4000/ul, or Hb<8g/dl), pregnant patients or women trying to conceive

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03275870

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United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Elena Gonzalez Brant, MD
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Principal Investigator: Elena M Gonzalez Brant, MD University of Pittsburgh
  Study Documents (Full-Text)

Documents provided by Elena Gonzalez Brant, MD, University of Pittsburgh:
Study Protocol  [PDF] September 1, 2017
Informed Consent Form  [PDF] September 1, 2017


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Responsible Party: Elena Gonzalez Brant, MD, Principal Investigator, University of Pittsburgh Identifier: NCT03275870    
Other Study ID Numbers: PRO17030612
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents