Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

Lichen Sclerosus Clinical Trial

Official title:

Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02794363
• Other study ID #: 604763-1
• Status: Completed
• Phase: N/A
• First received: May 25, 2016
• Last updated: June 4, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: June 2016
• Source: Center for Vulvovaginal Disorders
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Active lichen sclerosus

• no current treatment

• symptomatic 4/10 on visual analogue scale

Exclusion Criteria:

• history of vulvar carcinoma or VIN

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lichen Sclerosus
• Lichen Sclerosus et Atrophicus
• Vulvar Lichen Sclerosus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Center for Vulvovaginal Disorders

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease in inflammation on post treatment biopsies	Pathologist will grade inflammation on 0-4 scale of pre and post treatment biopsies	14 weeks	No
Secondary	Decrease in Pruritus	Participants will fill out a 10cm visual analogue scale that grade the amount of their pruritus (itching)	14 weeks	No
Secondary	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	No