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Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Primary Purpose

Lichen Sclerosus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Autologous platelet rich plasma
Sponsored by
Center for Vulvovaginal Disorders
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Active lichen sclerosus
  • no current treatment
  • symptomatic 4/10 on visual analogue scale

Exclusion Criteria:

  • history of vulvar carcinoma or VIN

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Autologous platelet rich plasma

    Arm Description

    Autologous platelet rich plasma injection into vulvar skin. There are no placebo, sham, or active comparator arms

    Outcomes

    Primary Outcome Measures

    Decrease in inflammation on post treatment biopsies
    Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies

    Secondary Outcome Measures

    Decrease in Pruritus
    Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching)
    Investigator Global Assessment
    The investigator will rate the severity of lichen sclerosus based on the amount of lichenification, fissures, and ulceration. This will be a 4 point scale.

    Full Information

    First Posted
    May 25, 2016
    Last Updated
    June 4, 2016
    Sponsor
    Center for Vulvovaginal Disorders
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02794363
    Brief Title
    Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus
    Official Title
    Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2014 (undefined)
    Primary Completion Date
    January 2016 (Actual)
    Study Completion Date
    April 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Center for Vulvovaginal Disorders

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period and a 12-week treatment period. Participants will receive two separate treatments of autologous platelet rich plasma separated by 6 weeks. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection
    Detailed Description
    15 patients with biopsy proven active vulvar lichen sclerosus will be recruited by a clinic specializing in vulvar disorders. This study consists of a 2 week screening period. A 4mm vulvar punch biopsy will be obtained at the initiation of the screening period to confirm that the participant have active lichen sclerosus. 12 weeks after the biopsy, the participants will receive an injection of 5cc of autologous platelet rich plasma into the affected vulvar skin. Six weeks later, participants will receive an additional injection of 5cc of autologous platelet rich plasma. A repeat biopsy will be performed 6 weeks after the second autologous platelet rich plasma injection. The inflammation on both biopsy specimens will be determined by a dermatopathologist.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lichen Sclerosus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Autologous platelet rich plasma
    Arm Type
    Other
    Arm Description
    Autologous platelet rich plasma injection into vulvar skin. There are no placebo, sham, or active comparator arms
    Intervention Type
    Biological
    Intervention Name(s)
    Autologous platelet rich plasma
    Intervention Description
    5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.
    Primary Outcome Measure Information:
    Title
    Decrease in inflammation on post treatment biopsies
    Description
    Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies
    Time Frame
    14 weeks
    Secondary Outcome Measure Information:
    Title
    Decrease in Pruritus
    Description
    Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching)
    Time Frame
    14 weeks
    Title
    Investigator Global Assessment
    Description
    The investigator will rate the severity of lichen sclerosus based on the amount of lichenification, fissures, and ulceration. This will be a 4 point scale.
    Time Frame
    14 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Active lichen sclerosus no current treatment symptomatic 4/10 on visual analogue scale Exclusion Criteria: history of vulvar carcinoma or VIN

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

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