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ViewAttendees 3

Session: ePoster Monitor 8 - Late Breaking ePosters 1

eP804 - Clascoterone in the Treatment of Pilonidal Sinus Disease: a Randomized Double-Blinded Vehicle Controlled Trial

Monday, June 3, 2024
10:36 AM – 10:41 AM ET, USA
Location: Room 318-320

    ePoster Presenter(s)

  • Jeffrey L. Roberson, MD

    Resident
    The Hospital of the University of Pennsylvania
    The Hospital of the University of Pennsylvania
    Philadelphia, PA, United States

    Disclosure information not submitted.

    • Author(s)

  • VF

    Victoria Fang, MD, PhD

    Postdoctoral Research Fellow
    The Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania, United States

    Disclosure information not submitted.

  • Nicole M. Saur, MD, FACS, FASCRS (she/her/hers)

    Associate Professor of Clinical Surgery
    University of Pennsylvania
    University of Pennsylvania
    Philadelphia, PA, United States

    All relevant financial disclosures have been managed and will be listed below.
    This individual has no relevant relationships with ineligible companies.

  • Joshua I. S Bleier, MD (he/him/his)

    Chair of Surgery, Pennsylvania Hospital; Program Director Colorectal Fellowship
    University of Pennsylvania
    University of Pennsylvania
    Bala Cynwyd, PA, United States

    Disclosure information not submitted.

  • EP

    Erica Pettke, MD, MPH, FACS

    Assistant Professor of Surgery
    University of Pennsylvania
    philadelphia, Pennsylvania, United States

    Disclosure information not submitted.

  • PH

    Paul Hernandez, MD

    Assistant Professor
    University of Pennsylvania, Division of Colon and Rectal Surgery
    Philadelphia, PA, United States

    All relevant financial disclosures have been managed and will be listed below.
    This individual has no financial relationships with ineligible companies.

  • Najjia N. Mahmoud, MD

    Physician
    University of Pennsylvania Health System
    University of Pennsylvania
    Philadelphia, Pennsylvania, United States

    All relevant financial disclosures have been managed and will be listed below.
    This individual has no financial relationships with ineligible companies.

  • CP

    Carter Paulson, MD MSCE

    Assistant Professor of Surgery
    Philadelphia VA Medical Center
    Philadelphia, Pennsylvania, United States

    Disclosure information not submitted.

  • JG

    Joel Gelfand, MD, MSCE, FAAD

    Vice Chair of Clinical Research and Medical Director, Dermatology Clinical Studies Unit
    The Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania, United States

    Disclosure information not submitted.

    • Senior Author(s)

  • LM

    Lillias Maguire, MD FACS

    Assistant Professor of Surgery
    University of Pennsylvania
    Philadelphia, Pennsylvania, United States

    Disclosure information not submitted.

Image or Table (Do Not add text here):

Purpose/Background: Pilonidal Sinus Disease (PSD) and its purely surgical treatment results in significant morbidity in young patients. There is an unmet need for novel non-surgical approaches. Our recent genetic data implicate androgens in development of PSD, concordant with the high incidence in young men and the pro-inflammatory role of androgens at the cellular level. Topical and systemic anti-androgens treat acne and hidradenitis suppurativa, but have never been trialed in PSD. Clascoterone is a novel topical androgen antagonist approved for use in acne. We propose a randomized, double-blinded, placebo-controlled trial of clascoterone in PSD, evaluating its effect on objective disease severity, patient quality of life, and subcutaneous inflammation.Methods/Interventions: We will recruit 50 adult patients with PSD considered for elective resection and perform a 1:1 randomization to 12 weeks of 1% clascoterone vs vehicle control. Patients will be assessed at baseline and weeks 4, 8, and 12 with medical photography and surveyed with the Dermatology Life Quality Index (DLQI). The DLQI has been validated in multiple conditions to measure disease impact on physical, physiological, and social quality of life. Finally, patients from either arm proceeding to surgery within 4 weeks will have a surgical sample collected for histologic immune profiling and followed for surgical outcomes.Results/Outcomes: We will assess the impact of clascoterone on objective, subjective, and subclinical outcomes. Objectively, blinded surgeons will score disease response to treatment. If clascoterone is a successful medical intervention, it should produce an obvious, visually appreciable improvement to surgeons familiar with PSD. Subjectively, we will compare DQLI scores at baseline, intermediate, and final time points between treatment and vehicle groups. We hypothesize that clascoterone treatment will improve PSD-specific quality of life over 12 weeks of treatment. Finally, we anticipate that many patients in both groups will undergo surgery. We will measure surgical variables and outcomes. Finally, we will investigate a potential subclinical aim of clascoterone by quantitatively and qualitatively scoring subcutaneous inflammation in PSD surgical specimens.Conclusion/

Discussion: This translational study is innovative in its bench to bedside approach of utilizing genomic data implicating androgen pathways in PSD to develop topical therapeutics. This study addresses an unmet clinical need to reduce the burden of PSD and its current therapies.