Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Vulvovaginal Disorders

Criteria

Inclusion Criteria:

• Female, 18 year or older

• With a diagnosis of biopsy proven active vulvar lichen sclerosus

• Signed written informed consent

• Willingness and ability to comply with the study requirements

• Subject must have a score of 5 or greater in the itching (pruritus) domain of the CSS upon enrollment

Exclusion Criteria:

• Who have received systemic immunosuppressants (e.g. corticosteroids) within 12 weeks prior to participation in the study

• Who have been treated with topical therapy (e.g. topical corticosteroids, topical calcineurin inhibitors, topical estrogen, topical testosterone) at the affected area within 16 weeks prior to participation in the study.

• Who are immunocompromised (e.g. lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have an uncontrolled malignant disease

• Who suffer from systemic of generalized infections (bacterial, viral, or fungal)

• Who have been diagnosed with lichen planus, psoriasis, candidiasis, intraepithelial neoplasia, or carcinoma of the vulva

• Who had received an investigational drug within four weeks prior to the study or who intend to use other investigational drugs during the course of this study.

• Patients with severe medical conditions(s) that in the view of the investigator prohibits participation in the study.

• Who have a history of substance abuse of any factor, which limits the subject's ability to cooperate in the study procedure

• Who are uncooperative, known to miss appointments (according to subjects' records) and are unlikely to follow medical instructions pr are not willing to attend regularly scheduled visits.