Platelet Rich Plasma (PRP) for Vulvar Lichen Sclerosus

Launched by CENTER FOR VULVOVAGINAL DISORDERS · Feb 3, 2017

Keywords

ClinConnect Summary

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 lich...

Gender

FEMALE

Eligibility 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.