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Trial record 3 of 9 for:    triad pittsburgh

Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa

This study is currently recruiting participants.
Verified November 2017 by Elena Gonzalez Brant, University of Pittsburgh
Sponsor:
ClinicalTrials.gov Identifier:
NCT03275870
First Posted: September 8, 2017
Last Update Posted: November 7, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Elena Gonzalez Brant, University of Pittsburgh
  Purpose

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 Intervention Phase
Hidradenitis Suppurativa Hidradenitis Acne Inversa Boils Follicular Occlusion Triad Follicular Occlusion Tetrad Drug: Hydroxychloroquine Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of Hydroxychloroquine for the Treatment of Hidradenitis Suppurativa

Resource links provided by NLM:


Further study details as provided by Elena Gonzalez Brant, University of Pittsburgh:

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


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


Estimated Enrollment: 20
Actual Study Start Date: September 28, 2017
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

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.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT03275870


Contacts
Contact: Elena M Gonzalez Brant, MD 412-647-4200 gonzalezbrantem@upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Elena M Gonzalez Brant, MD    412-647-4200    gonzalezbrantem@upmc.edu   
Principal Investigator: Elena M Gonzalez Brant, MD         
Sub-Investigator: Oleg Akilov, MD, PhD         
Sponsors and Collaborators
Elena Gonzalez Brant
Investigators
Principal Investigator: Elena M Gonzalez Brant, MD University of Pittsburgh
  Study Documents (Full-Text)

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

  More Information

Publications:

Responsible Party: Elena Gonzalez Brant, Principal Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03275870     History of Changes
Other Study ID Numbers: PRO17030612
First Submitted: August 31, 2017
First Posted: September 8, 2017
Last Update Posted: November 7, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Hidradenitis
Hidradenitis Suppurativa
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration
Hydroxychloroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents