Ignite Creation Date:
2024-05-06 @ 9:41 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03045172
Status:
COMPLETED
Last Update Posted:
2018-10-25
First Post:
2017-02-01
Brief Title:
Platelet Rich Plasma PRP for Vulvar Lichen Sclerosus
Sponsor:
Center for Vulvovaginal Disorders
Organization:
Center for Vulvovaginal Disorders
Study Overview
Official Title:
A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma PRP Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lichen sclerosus LS is a skin condition of the external genitals vulva of women LS causes vulvar itching pain and burning In addition LS causes scarring of the vulva which may cause significant sexual dysfunction or pain Lastly 4-6 of women with LS will develop vulvar cancer
The current gold standard treatment for lichen sclerosus is potent steroids creams When used correctly steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying inflammation of LS and may lower the risk of getting cancer While useful steroid creams may have serious side effects that include thinning of the skin fungal infections and lowering the immune system
Platelet-rich plasma PRP is a platelet concentrate that helps to speed up tissue healing without serious side effects in a very wide range of medical conditions such as diabetic foot ulcers muscle injury tendon injury and in a variety of cosmetic procedures The PRP works because of its high level of proteins that help with wound healing It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects
Recently there was an exploratory study of twelve subjects that used PRP for the study treatment of lichen sclerosus While this study showed good success the study was limited because of its small size and lack of placebo a drug or study treatment that contains no active ingredient control
The current gold standard treatment for lichen sclerosus is potent steroids creams When used correctly steroid creams help to decrease the symptoms of itching and burning and can prevent further vulvar scarring In addition proper treatment reverses the underlying inflammation of LS and may lower the risk of getting cancer While useful steroid creams may have serious side effects that include thinning of the skin fungal infections and lowering the immune system
Platelet-rich plasma PRP is a platelet concentrate that helps to speed up tissue healing without serious side effects in a very wide range of medical conditions such as diabetic foot ulcers muscle injury tendon injury and in a variety of cosmetic procedures The PRP works because of its high level of proteins that help with wound healing It is also apparent from the majority of published studies that PRP therapy has minimal risk of scar tissue formation or significant bad side effects
Recently there was an exploratory study of twelve subjects that used PRP for the study treatment of lichen sclerosus While this study showed good success the study was limited because of its small size and lack of placebo a drug or study treatment that contains no active ingredient control
Detailed Description:
This will be a randomized single-blind placebo controlled trial to evaluate the efficacy and safety of autologous Platelet-rich Plasma PRP for the treatment of vulvar lichen sclerosus Thirty patients with a diagnosis of biopsy proven active vulvar lichen sclerosus will be recruited from one center This study will consist of a two-week screening period and a 12-week treatment period At the beginning of the screening period a 4 millimeter punch skin biopsy sample will be collected from each patient to confirm the diagnosis of active lichen sclerosus and to rule out the diagnoses of lichen planus psoriasis candidiasis and vulvar intraepithelial neoplasia In addition vulvoscopy will be performed at the screening visit and after the 12-week treatment period to rule out vulvar carcinoma All eligible patients will be randomized to receive either placebo saline injections 10 subjects or two separate treatments of PRP separated by 6 weeks 20 subjects Each treatment would consist of an injection of 5 ml of autologous platelet-rich plasma PRP injected subdermally and intra-dermally infiltrating the areas of the vulva affected by active lichen sclerosus A repeat biopsy will be performed adjacent to the original biopsy site at the 12 week visit
The preparation of autologous PRP is as follows 60 cc of whole blood will be removed via venopuncture Preparation of PRP is done using a proprietary FDA approved centrifuge which uses a laser and a closed sterile system to identify and isolate the most platelet rich fraction of 60ml of whole blood Magellan Autologous Platelet Separator System Arteriocyte Medical Systems Hopkinton MA USA
The PRP will be collected in a blackened syringe so that neither Dr Goldstein the physician administering the PRP nor the patient will know if she is receiving the PRP or placebo
After isolation of the PRP calcium chloride 07ml will be added to the 5 ml of PRP isolate to activate the thrombin cascade thereby causing degranulation of platelets releasing growth factors and cytokines and starting the transformation of the PRP to platelet rich fibrin matrix PRFM
The primary efficacy variable will be performed by a blinded dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and at the Week 14 visit 1 to 4 scales A secondary endpoint will be changes from baseline in the Clinical Scoring System for Vulvar Lichen Sclerosus CSS a validated instrument that assessment both an investigators impression of the severity of disease and a patients impression of the severity of her disease
All adverse events will be recorded including serious adverse events A physical examination will be performed at each visit
The preparation of autologous PRP is as follows 60 cc of whole blood will be removed via venopuncture Preparation of PRP is done using a proprietary FDA approved centrifuge which uses a laser and a closed sterile system to identify and isolate the most platelet rich fraction of 60ml of whole blood Magellan Autologous Platelet Separator System Arteriocyte Medical Systems Hopkinton MA USA
The PRP will be collected in a blackened syringe so that neither Dr Goldstein the physician administering the PRP nor the patient will know if she is receiving the PRP or placebo
After isolation of the PRP calcium chloride 07ml will be added to the 5 ml of PRP isolate to activate the thrombin cascade thereby causing degranulation of platelets releasing growth factors and cytokines and starting the transformation of the PRP to platelet rich fibrin matrix PRFM
The primary efficacy variable will be performed by a blinded dermatopathologist who will evaluate the inflammatory infiltration on biopsy specimens obtained during the screening period and at the Week 14 visit 1 to 4 scales A secondary endpoint will be changes from baseline in the Clinical Scoring System for Vulvar Lichen Sclerosus CSS a validated instrument that assessment both an investigators impression of the severity of disease and a patients impression of the severity of her disease
All adverse events will be recorded including serious adverse events A physical examination will be performed at each visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None