NCT03045172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1.7 years

First QC Date

February 1, 2017

Last Update Submit

October 23, 2018

Conditions

Lichen Sclerosus of Vulva

Keywords

Lichen SclerosusPlatelet Rich PlasmaVulvarVulva

Outcome Measures

Primary Outcomes (1)

  • Clinical Scoring System for Vulvar Lichen Sclerosus

    A validated instrument that assesses both the investigator's impression of the severity of disease and a patient's impression of the severity of her disease pre and post-intervention.

    14 weeks

Study Arms (2)

Group 1

ACTIVE COMPARATOR

20 subjects with Platelet Rich Plasma injections

Biological: Platelet Rich Plasma

Group 2

PLACEBO COMPARATOR

10 subjects with placebo injections

Drug: Placebo

Interventions

Platelet Rich PlasmaBIOLOGICAL

PRP

Group 1
PlaceboDRUG

Saline

Group 2

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Vulvovaginal Disorders

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (13)

  • Pierard GE, Pierard-Franchimont C, Ben Mosbah T, Arrese Estrada J. Adverse effects of topical corticosteroids. Acta Derm Venereol Suppl (Stockh). 1989;151:26-30; discussion 47-52.

    PMID: 2624063BACKGROUND

  • Lubach D, Rath J, Kietzmann M. Steroid-induced dermal thinning: discontinuous application of clobetasol-17-propionate ointment. Dermatology. 1992;185(1):44-8. doi: 10.1159/000247402.

    PMID: 1638070BACKGROUND

  • Cherian MP, AbdulJabbar M. Cushing's syndrome and adrenal suppression from percutaneous absorption of clobetasol propionate in infants. Saudi Med J. 2001 Dec;22(12):1139-41. No abstract available.

    PMID: 11802195BACKGROUND

  • Furue M, Terao H, Rikihisa W, Urabe K, Kinukawa N, Nose Y, Koga T. Clinical dose and adverse effects of topical steroids in daily management of atopic dermatitis. Br J Dermatol. 2003 Jan;148(1):128-33. doi: 10.1046/j.1365-2133.2003.04934.x.

    PMID: 12534606BACKGROUND

  • Sarvajnamurthy S, Suryanarayan S, Budamakuntala L, Suresh DH. Autologous platelet rich plasma in chronic venous ulcers: study of 17 cases. J Cutan Aesthet Surg. 2013 Apr;6(2):97-9. doi: 10.4103/0974-2077.112671.

    PMID: 24023432BACKGROUND

  • Sclafani AP. Safety, efficacy, and utility of platelet-rich fibrin matrix in facial plastic surgery. Arch Facial Plast Surg. 2011 Jul-Aug;13(4):247-51. doi: 10.1001/archfacial.2011.3. Epub 2011 Feb 21.

    PMID: 21339469BACKGROUND

  • Chen L, Yang X, Huang G, Song D, Ye XS, Xu H, Li W. Platelet-rich plasma promotes healing of osteoporotic fractures. Orthopedics. 2013 Jun;36(6):e687-94. doi: 10.3928/01477447-20130523-10.

    PMID: 23746028BACKGROUND

  • Goldstein AT, King M, Runels C, Gloth M, Pfau R. Intradermal injection of autologous platelet-rich plasma for the treatment of vulvar lichen sclerosus. J Am Acad Dermatol. 2017 Jan;76(1):158-160. doi: 10.1016/j.jaad.2016.07.037. No abstract available.

    PMID: 27986140BACKGROUND

  • Lubkowska A, Dolegowska B, Banfi G. Growth factor content in PRP and their applicability in medicine. J Biol Regul Homeost Agents. 2012 Apr-Jun;26(2 Suppl 1):3S-22S.

    PMID: 23648195BACKGROUND

  • Salazar-Alvarez AE, Riera-del-Moral LF, Garcia-Arranz M, Alvarez-Garcia J, Concepcion-Rodriguez NA, Riera-de-Cubas L. Use of platelet-rich plasma in the healing of chronic ulcers of the lower extremity. Actas Dermosifiliogr. 2014 Jul-Aug;105(6):597-604. doi: 10.1016/j.ad.2013.12.011. Epub 2014 Mar 12. English, Spanish.

    PMID: 24630241BACKGROUND

  • Moraes VY, Lenza M, Tamaoki MJ, Faloppa F, Belloti JC. Platelet-rich therapies for musculoskeletal soft tissue injuries. Cochrane Database Syst Rev. 2013 Dec 23;(12):CD010071. doi: 10.1002/14651858.CD010071.pub2.

    PMID: 24363098BACKGROUND

  • Casabona F, Priano V, Vallerino V, Cogliandro A, Lavagnino G. New surgical approach to lichen sclerosus of the vulva: the role of adipose-derived mesenchymal cells and platelet-rich plasma in tissue regeneration. Plast Reconstr Surg. 2010 Oct;126(4):210e-211e. doi: 10.1097/PRS.0b013e3181ea9386. No abstract available.

    PMID: 20885230BACKGROUND

  • Gunthert AR, Duclos K, Jahns BG, Krause E, Amann E, Limacher A, Mueller MD, Juni P. Clinical scoring system for vulvar lichen sclerosus. J Sex Med. 2012 Sep;9(9):2342-50. doi: 10.1111/j.1743-6109.2012.02814.x. Epub 2012 Jul 3.

    PMID: 22759453BACKGROUND

MeSH Terms

Conditions

Vulvar Lichen SclerosusLichen Sclerosus et Atrophicus

Condition Hierarchy (Ancestors)

Vulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesLichenoid EruptionsSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Andrew T Goldstein, MD

    The Center for Vulvovaginal Disorders

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Dermatopathologist
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2017

First Posted

February 7, 2017

Study Start

November 1, 2016

Primary Completion

August 1, 2018

Study Completion

October 1, 2018

Last Updated

October 25, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Available IPD Datasets

Informed Consent Form Access

Locations

US(1)