Lichen Sclerosus of Vulva Clinical Trial
Official title:
A Double Blind Placebo Controlled Trial of Autologous Platelet Rich Plasma (PRP) Intradermal Injections for the Treatment of Vulvar Lichen Sclerosus
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.
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 (0.7ml) 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 investigator's impression of the severity of disease and a
patient's 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05953090 -
VALOR: Vaginal Atrophy & Long-term Observation of Recovery
|
N/A | |
| Not yet recruiting |
NCT05364515 -
Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
|
Phase 3 |