A Study to Evaluate Platelet Rich Plasma to Treat Vulvar Lichen Sclerosus

Overview

About this study

The purposes of this study are to determine the safety and feasibility of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus, and to determine the efficacy of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Female, ages 18 years and greater.
  • Females of childbearing potential must have a negative pregnancy test prior to receiving the study drug and will agree to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening to a period of 1 year following completion of the drug treatment cycle.  Females of childbearing potential are defined as premenopausal and not surgically sterilized, or post-menopausal for fewer than 2 years.  A urine pregnancy test will be performed prior to the administration of the study drug to confirm negative results.  If the urine pregnancy test is positive, the study drug will not be administered and the result will be confirmed by a serum pregnancy test. Serum pregnancy tests will be performed at a central clinical laboratory, whereas urine pregnancy tests will be performed by qualified personnel using kit.
  • Females becoming pregnant during the study will continue to be monitored for the duration of the study or completion of the pregnancy, whichever is longer.  Monitoring will include perinatal and neonatal outcome.  Any SAEs associated with pregnancy will be recorded.   
  • Diagnosis of Lichen Sclerosus based on clinical and/or histological assessment.
  • On a maintenance regimen of topical clobetasol for Lichen Sclerosus.  Maintenance is defined as use of topical clobetasol 3 or fewer days per week.  For patients with a new diagnosis of Lichen Sclerosus, they will complete 6 weeks of topical clobetasol ointment twice daily prior to enrollment in the study with transition to use of topical steroids as needed during the study period.
  • Residual symptoms despite topical corticosteroid use as evidenced by a patient-administered symptom score of 10 or higher on Clinical Scoring System for Lichen Sclerosus. 
  • Residual active lichen sclerosus despite topical corticosteroid use as evidenced by a physician-administered symptom score of 3 or higher on Clinical Scoring System for Lichen Sclerosus. 
  • Completed general physical evaluation with primary care provider within 12 months of enrollment.
  • Full understanding of the requirements of the study and willingness to comply with protocol.
  • Can provide written informed consent and complete HIPAA documentation after the nature of the study is fully explained and prior to any study-related procedure

Exclusion Criteria:

  • Pregnant or nursing, or planning on becoming pregnant during the study period.
  • Clinically significant abnormal hematology (white blood cell count less than 3 or greater than 10 x 10^9/L, hemoglobin less than 9.5 or greater than 15.5 g/dL, or platelet count less than 130 or greater than 450 x 10^9/L ).  These reference ranges may change if normal reference ranges are changed by the performing laboratory.
  • Taking anticoagulant medications (e.g., warfarin, heparin) or clopidogrel (Plavix).
  • Taking anti-rheumatic disease medication (including methotrexate or other antimetabolites) within 3 months prior to study enrollment.
  • On chronic, immunosuppressive transplant therapy or having a chronic, immunosuppressive state, including use of systemic steroids/corticosteroids.
  • Using topical steroids on affected area and unable to stop for the 6 week washout period prior to beginning the study.  Topical steroid use will be exclusionary throughout week 12 of the study for patients randomized to receive PRP. 
  • Current tobacco product use, including nicotine patch or other nicotine products.
  • History of an active clinically significant infectious disease, including but not limited to tuberculosis, HIV, hepatitis, and syphilis.  Clinical significance will be determined by the Principal Investigator.
  • Known history of clinically significant cardiovascular (e.g., history of myocardial infarction, congestive heart failure or uncontrolled hypertension > 90 mmHg diastolic and/or 180 mmHg systolic), neurologic (e.g., stroke, TIA) renal, hepatic, or endocrine disease (e.g., diabetes). Clinical significance will be determined by the Principal Investigator.
  • History of cancer/malignancy within the last 5 years with the exception of any adequately treated cancer/malignancy with no evidence of reoccurrence.
  • History of blood dyscrasia, including but not limited to anemia, thrombocytopenia, and monoclonal gammopathy.
  • Participation in a study of an experimental drug or medical device within 3 months of study enrollment.
  • Known allergy to local anesthetics of other components of the study drug.
  • History of or current evidence of alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have use of medical marijuana within 30 days of study entry.
  • Any illness or condition which, in the investigators’ judgement will interfere with the patient’s ability to comply with the protocol, compromise patient safety, or interfere with the interpretation of the study results.

Eligibility last updated 8/12/21. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Katherine Bodiford, M.D.

Open for enrollment

Contact information:

Thomas Morse

(904) 953-4359

Morse.Thomas@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

.
CLS-20517235

Mayo Clinic Footer