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
About this trial
This is an interventional treatment trial for Lichen Sclerosus
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
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
NCT ID
NCT02794363
First Posted
May 25, 2016
Last Updated
June 4, 2016
Sponsor
Center for Vulvovaginal Disorders
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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