NCT02794363

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 9, 2016

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

1.7 years

First QC Date

May 25, 2016

Last Update Submit

June 4, 2016

Conditions

Lichen Sclerosus

Outcome Measures

Primary Outcomes (1)

  • Decrease in inflammation on post treatment biopsies

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

    14 weeks

Secondary Outcomes (2)

  • Decrease in Pruritus

    14 weeks

  • Investigator Global Assessment

    14 weeks

Study Arms (1)

Autologous platelet rich plasma

OTHER

Autologous platelet rich plasma injection into vulvar skin. There are no placebo, sham, or active comparator arms

Biological: Autologous platelet rich plasma

Interventions

Autologous platelet rich plasmaBIOLOGICAL

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

Autologous platelet rich plasma

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of vulvar carcinoma or VIN

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Lichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2016

First Posted

June 9, 2016

Study Start

May 1, 2014

Primary Completion

January 1, 2016

Study Completion

April 1, 2016

Last Updated

June 9, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share