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Trial record 13 of 25 for:    "Lichen Sclerosus"

Platelet Rich Plasma Injections for Vulvar Lichen Sclerosus

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ClinicalTrials.gov Identifier: NCT02794363
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : June 9, 2016
Sponsor:
Information provided by (Responsible Party):
Center for Vulvovaginal Disorders

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

Condition or disease Intervention/treatment Phase
Lichen Sclerosus Biological: Autologous platelet rich plasma Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Platelet Rich Plasma Intradermal Injections for Vulvar Lichen Sclerosus
Study Start Date : May 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • history of vulvar carcinoma or VIN

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Responsible Party: Center for Vulvovaginal Disorders
ClinicalTrials.gov Identifier: NCT02794363     History of Changes
Other Study ID Numbers: 604763-1
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: June 9, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Vulvar Lichen Sclerosus
Lichen Sclerosus et Atrophicus
Lichenoid Eruptions
Skin Diseases, Papulosquamous
Skin Diseases
Vulvar Diseases
Genital Diseases, Female