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Complement C5a Receptors in Hidradenitis Suppurativa

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ClinicalTrials.gov Identifier: NCT04251663
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Kavita Sarin, Stanford University

Brief Summary:
To study the role of C5a in Hidradenitis Suppurativa (HS). Complement C5a is a major chemotactic factor that stimulates neutrophil infiltration.

Condition or disease
Hidradenitis Suppurativa

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Examine the Roles of Complement C5a Receptors in Hidradenitis Suppurativa by ex Vivo Studies
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : January 20, 2021
Estimated Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine


Group/Cohort
HS subjects
Subjects with active HS disease, among which at least 5 will be treatment-naïve
Healthy Controls
Healthy subjects



Primary Outcome Measures :
  1. CD11b surface expression on neutrophils [ Time Frame: Day 1 study visit (up to 2 hours) ]
    Relative expression of adhesion molecule (CD11b) on circulating neutrophils in HS patients determined by flow cytometry.

  2. C5aR surface expression on neutrophils [ Time Frame: Day 1 study visit (up to 2 hours) ]
    Relative expression of canonical complement 5a receptor (C5aR) on circulating neutrophils in HS patients determined by flow cytometry.


Secondary Outcome Measures :
  1. Immune cell population profiling [ Time Frame: Day 1 study visit (up to 2 hours) ]
    Immune cell population profile as measured by the percentage of circulating neutrophils, macrophage and T cells as determined by flow cytometry.

  2. Measurement of cytokines [ Time Frame: Day 1 study visit (up to 2 hours) ]
    Skin biopsies will be cultured ex vivo. Cytokine profile as measured by the level of cytokines in assay supernatant by multiplex ELISA: IL-1β, IL-6, TNF-α, IL-12, IL-23, IL-17A, IL-17F, IFN-γ.


Other Outcome Measures:
  1. Complement factor analysis [ Time Frame: Day 1 study visit (up to 2 hours) ]
    Complement factor (such as C1q, C4d, Bb, iC3b, C5b-9) will be analyzed by immunohistochemistry on biopsy samples (pending extra tissue availability after flow cytometry analysis)..



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The team will collect plasma and tissue samples from 20 HS patients with active disease, among which at least 5 will be treatment-naïve. Plasma from 10 healthy volunteers will be used as controls.

The team will try to obtain blood and 2 skin biopsies (1 from a HS lesion, 1 from normal skin).

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Willing to sign consent and provide a blood sample
  • Willing to provide 2 skin biopsies - lesional and perilesional
  • Active HS disease or healthy volunteer

Exclusion Criteria:

  • None

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): NCT04251663


Contacts
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Contact: Clinical Trial Coordinator 6507217149 baileyhi@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Redwood City, California, United States, 94063
Contact: Clinical Trial Coordinator    650-721-7149    baileyhi@stanford.edu   
Sub-Investigator: Aatman Shah         
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Kavita Y Sarin, MD PhD Stanford University
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Responsible Party: Kavita Sarin, Assistant Professor of Dermatology, Stanford University
ClinicalTrials.gov Identifier: NCT04251663    
Other Study ID Numbers: 51335
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration