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Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus

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: NCT03045172
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : October 25, 2018
Information provided by (Responsible Party):
Center for Vulvovaginal Disorders

Tracking Information
First Submitted Date  ICMJE February 1, 2017
First Posted Date  ICMJE February 7, 2017
Last Update Posted Date October 25, 2018
Study Start Date  ICMJE November 2016
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
Clinical Scoring System for Vulvar Lichen Sclerosus [ Time Frame: 14 weeks ]
A validated instrument that assesses both the investigator's impression of the severity of disease and a patient's impression of the severity of her disease pre and post-intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03045172 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus
Official Title  ICMJE A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus
Brief Summary

Lichen sclerosus (LS) is a skin condition of the external genitals (vulva) of women. LS causes vulvar itching, pain, and burning. In addition, LS causes scarring of the vulva which may cause significant sexual dysfunction or pain. Lastly, 4-6% of women with LS will develop vulvar cancer.

The current "gold standard" treatment for lichen sclerosus is potent steroids creams. When used correctly, steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring. In addition, proper treatment reverses the underlying inflammation of LS, and may lower the risk of getting cancer. While useful, steroid creams may have serious side effects that include thinning of the skin, fungal infections, and lowering the immune system.

Platelet-rich plasma (PRP) is a platelet concentrate that helps to speed up tissue healing, without serious side effects, in a very wide range of medical conditions such as diabetic foot ulcers, muscle injury, tendon injury, and in a variety of cosmetic procedures. The PRP works because of its high level of proteins that help with wound healing. It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects.

Recently, there was an exploratory study of twelve subjects that used PRP for the study treatment of lichen sclerosus. While this study showed good success, the study was limited because of its small size and lack of placebo (a drug or study treatment that contains no active ingredient) control.

Detailed Description

This will be a randomized single-blind placebo controlled trial to evaluate the efficacy and safety of autologous Platelet-rich Plasma (PRP) for the treatment of vulvar lichen sclerosus. Thirty patients with a diagnosis of biopsy proven active vulvar lichen sclerosus will be recruited from one center. This study will consist of a two-week screening period and a 12-week treatment period. At the beginning of the screening period, a 4 millimeter punch skin biopsy sample will be collected from each patient to confirm the diagnosis of active lichen sclerosus and to rule out the diagnoses of lichen planus, psoriasis, candidiasis, and vulvar intraepithelial neoplasia. In addition, vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar carcinoma. All eligible patients will be randomized to receive either placebo (saline injections) (10 subjects) or two separate treatments of PRP separated by 6 weeks (20 subjects). Each treatment would consist of an injection of 5 ml of autologous platelet-rich plasma (PRP) injected subdermally and intra-dermally, infiltrating the areas of the vulva affected by active lichen sclerosus. A repeat biopsy will be performed adjacent to the original biopsy site at the 12 week visit.

The preparation of autologous PRP is as follows: 60 cc of whole blood will be removed via venopuncture. Preparation of PRP is done using a proprietary, FDA approved, centrifuge which uses a laser and a closed sterile system to identify and isolate the most platelet rich fraction of 60ml of whole blood. [Magellan® Autologous Platelet Separator System. Arteriocyte Medical Systems. Hopkinton, MA USA].

The PRP will be collected in a blackened syringe so that neither Dr. Goldstein (the physician administering the PRP) nor the patient will know if she is receiving the PRP or placebo.

After isolation of the PRP, calcium chloride (0.7ml) will be added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM).

The primary efficacy variable will be performed by a blinded dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and at the Week 14 visit (1 to 4 scales). A secondary endpoint will be changes from baseline in the "Clinical Scoring System for Vulvar Lichen Sclerosus" (CSS) a validated instrument that assessment both an investigator's impression of the severity of disease and a patient's impression of the severity of her disease.

All adverse events will be recorded, including serious adverse events. A physical examination will be performed at each visit.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description:
Primary Purpose: Treatment
Condition  ICMJE Lichen Sclerosus of Vulva
Intervention  ICMJE
  • Biological: Platelet Rich Plasma
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Group 1
    20 subjects with Platelet Rich Plasma injections
    Intervention: Biological: Platelet Rich Plasma
  • Placebo Comparator: Group 2
    10 subjects with placebo injections
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 2, 2018)
Original Estimated Enrollment  ICMJE
 (submitted: February 3, 2017)
Actual Study Completion Date  ICMJE October 2018
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female, 18 year or older
  • With a diagnosis of biopsy proven active vulvar lichen sclerosus
  • Signed written informed consent
  • Willingness and ability to comply with the study requirements
  • Subject must have a score of 5 or greater in the itching (pruritus) domain of the CSS upon enrollment

Exclusion Criteria:

  • Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study
  • Who have been treated with topical therapy (e.g. topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 16 weeks prior to participation in the study.
  • Who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease
  • Who suffer from systemic of generalized infections (bacterial, viral, or fungal)
  • Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva
  • Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.
  • Patients with severe medical conditions(s) that in the view of the investigator prohibits participation in the study.
  • Who have a history of substance abuse of any factor, which limits the subject's ability to cooperate in the study procedure
  • Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions pr are not willing to attend regularly scheduled visits.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03045172
Other Study ID Numbers  ICMJE GCRF-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Center for Vulvovaginal Disorders
Study Sponsor  ICMJE Center for Vulvovaginal Disorders
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew T Goldstein, MD The Center for Vulvovaginal Disorders
PRS Account Center for Vulvovaginal Disorders
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP