Skip to main content
OpenTrials
Completed

NCT Number: NCT02794363

Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lichen Sclerosus Lichen Sclerosus et Atrophicus Lichenoid Eruptions Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • history of vulvar carcinoma or VIN

Treatment and study plan

Autologous Platelet Rich Plasma

Biological

5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.

Primary outcomes

  1. Decrease in inflammation on post treatment biopsies

    Time frame: 14 weeks

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

Secondary outcomes

  1. Decrease in Pruritus

    Time frame: 14 weeks

    Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching)

  2. Investigator Global Assessment

    Time frame: 14 weeks

    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.

Sponsors and collaborators

Lead sponsor

Center for Vulvovaginal Disorders

Other

Registry information

Official study title

Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 9, 2016
Registry last updated
Jun 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.