Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Autologous Platelet Rich Plasma Intradermal 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

Study Overview

• Status: Completed
• Conditions: Lichen Sclerosus
• Intervention / Treatment: Biological: Autologous platelet rich plasma

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

• history of vulvar carcinoma or VIN

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Autologous platelet rich plasma; Autologous platelet rich plasma injection into vulvar skin. There are no placebo, sham, or active comparator arms	Biological: Autologous platelet rich plasma; 5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in inflammation on post treatment biopsies	Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease in Pruritus	Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching)	14 weeks
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.	14 weeks

Collaborators and Investigators

• Sponsor: Center for Vulvovaginal Disorders

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 25, 2016
• First Submitted That Met QC Criteria: June 4, 2016
• First Posted (Estimate): June 9, 2016

Study Record Updates

• Last Update Posted (Estimate): June 9, 2016
• Last Update Submitted That Met QC Criteria: June 4, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Vulvar Diseases; Lichenoid Eruptions; Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
• Other Study ID Numbers: 604763-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No