Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.

NCT03961126 | Completed Phase 2

• 1 other identifier: LIQUENIA
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

LIQUENIA clinical trial is a phase II, controlled, prospective and unicentric study to assess vulvar lichen sclerosus (VLS) treatment using adipose tissue associated with autologous platelet-rich plasma (PRP) coming from the inner side of the patients' thighs, which aims to restore the structure and elasticity of the affected vulvar subunits, and to improve vulvar subunits lesions and symptoms, therefore, patients' quality of life from the early phases of the treatment.

Conditions

Vulvar Lichen Sclerosus

Keywords

Vulvar Lichen Sclerosus; Autologous Platelet-rich Plasma (PRP)

Outcome Measures

Primary Outcomes (6)

• Vulvar elasticity measured by the cutometer-dualmpa®

  Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

  Month 1 after first infiltration.

• Vulvar elasticity measured by the cutometer-dualmpa®

  Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

  Month 3 after first infiltration.

• Vulvar elasticity measured by the cutometer-dualmpa®

  Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

  Month 6 after first infiltration.

• Vulvar elasticity measured by the cutometer-dualmpa®

  Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

  Year 1 after first infiltration.

• Vulvar elasticity measured by the cutometer-dualmpa®

  Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

  Month 3 after second infiltration.

• Vulvar elasticity measured by the cutometer-dualmpa®

  Vulvar elasticity will be measured by the cutometer-dualmpa® for the analysis of the elasticity improvement in the plaques of fibrosis at the affected vulvar areas.

  Month 9 after second infiltration.

Secondary Outcomes (6)

• Histological improvement measured by the scale for histological assessment.

  Month 6

• Improvement in the quality of patients' life measured by skindex-29 questionnaire quality of life.

  Month 1, Month 3, Month 6, Year 1

• Improvement in the clinical symptoms by clinical assessment scale.

  Month 1, Month 3, Month 6, Year 1

• Improvement in the pruritus measured by 4D Pruritus Scale.

  Month 1, Month 3, Month 6, Year 1

• Improvement in the pain measured by Pain Scale.

  Month 1, Month 3, Month 6, Year 1

Study Arms (2)

Group autologous platelet-rich plasma injection

EXPERIMENTAL

Patients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar.

Drug: Injection of autologous fatty tissue associated with autologous platelet-rich plasma.

Group Control

ACTIVE COMPARATOR

Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.

Drug: Corticosteroids (clobetasol 0.05%)

Interventions

Injection of autologous fatty tissue associated with autologous platelet-rich plasma. DRUG

Patients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar.

Also known as: Experimental

Group autologous platelet-rich plasma injection

Corticosteroids (clobetasol 0.05%) DRUG

Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.

Also known as: Control

Group Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Gender Eligibility Details: Adult women between 18 and 70 years old
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women between 18 and 70 years old.
• Patients with clear clinical and/or histological diagnosis of vulvar lichen sclerosus (VLS).
• Moderate to severe affectation of the disease at genital level.
• Patients who have taken topical treatment for at least three months with 0.05% clobetasol propionate.
• Prior signed informed consent form.

You may not qualify if:

• Pregnant or lactating women.
• Alcoholic patients.
• Patients with malignant disease diagnosed in the last 5 years.
• Patients infected with HSV-II, HPV, HIV, HBV and HCV viruses.
• Injecting drug users.
• Patients with serious active infectious diseases.
• Patients with known allergy or intolerance to any of the aforementioned treatments.
• Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, psoriasis, eczema).
• Patients with unrealistic expectations regarding the final benefits of the treatment.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Spain

Location

Related Publications (14)

• Tausch TJ, Peterson AC. Early aggressive treatment of lichen sclerosus may prevent disease progression. J Urol. 2012 Jun;187(6):2101-5. doi: 10.1016/j.juro.2012.01.071. Epub 2012 Apr 12.

  PMID: 22503028 BACKGROUND

• Giuseppina Onesti M, Carella S, Ceccarelli S, Marchese C, Scuderi N. The Use of Human Adipose-Derived Stem Cells in the Treatment of Physiological and Pathological Vulvar Dystrophies. Stem Cells Int. 2016;2016:2561461. doi: 10.1155/2016/2561461. Epub 2016 Jan 10.

  PMID: 26880944 BACKGROUND

• Boero V, Brambilla M, Sipio E, Liverani CA, Di Martino M, Agnoli B, Libutti G, Cribiu FM, Del Gobbo A, Ragni E, Bolis G. Vulvar lichen sclerosus: A new regenerative approach through fat grafting. Gynecol Oncol. 2015 Dec;139(3):471-5. doi: 10.1016/j.ygyno.2015.10.014. Epub 2015 Oct 21.

  PMID: 26499935 BACKGROUND

• Tamburino S, Lombardo GA, Tarico MS, Perrotta RE. The Role of Nanofat Grafting in Vulvar Lichen Sclerosus: A Preliminary Report. Arch Plast Surg. 2016 Jan;43(1):93-5. doi: 10.5999/aps.2016.43.1.93. Epub 2016 Jan 15. No abstract available.

  PMID: 26848453 BACKGROUND

• Focseneanu MA, Gupta M, Squires KC, Bayliss SJ, Berk D, Merritt DF. The course of lichen sclerosus diagnosed prior to puberty. J Pediatr Adolesc Gynecol. 2013 Jun;26(3):153-5. doi: 10.1016/j.jpag.2012.12.002. Epub 2013 Mar 16.

  PMID: 23507004 BACKGROUND

• Gale KL, Rakha EA, Ball G, Tan VK, McCulley SJ, Macmillan RD. A case-controlled study of the oncologic safety of fat grafting. Plast Reconstr Surg. 2015 May;135(5):1263-1275. doi: 10.1097/PRS.0000000000001151.

  PMID: 25919241 BACKGROUND

• Sinno S, Wilson S, Brownstone N, Levine SM. Current Thoughts on Fat Grafting: Using the Evidence to Determine Fact or Fiction. Plast Reconstr Surg. 2016 Mar;137(3):818-824. doi: 10.1097/01.prs.0000479966.52477.8b.

  PMID: 26910662 BACKGROUND

• Sehgal VN, Pandhi D, Khurana A. Nonspecific genital ulcers. Clin Dermatol. 2014 Mar-Apr;32(2):259-74. doi: 10.1016/j.clindermatol.2013.08.024.

  PMID: 24559562 BACKGROUND

• Fuh KC, Berek JS. Current management of vulvar cancer. Hematol Oncol Clin North Am. 2012 Feb;26(1):45-62. doi: 10.1016/j.hoc.2011.10.006.

  PMID: 22244661 BACKGROUND

• Erickson BA, Elliott SP, Myers JB, Voelzke BB, Smith TG 3rd, McClung CD, Alsikafi NF, Vanni AJ, Brant WO, Broghammer JA, Tam CA, Zhao LC, Buckley JC, Breyer BN; Trauma and Urologic Reconstructive Network of Surgeons. Understanding the Relationship between Chronic Systemic Disease and Lichen Sclerosus Urethral Strictures. J Urol. 2016 Feb;195(2):363-8. doi: 10.1016/j.juro.2015.08.096. Epub 2015 Sep 5.

  PMID: 26343349 BACKGROUND

• Arrowsmith S, Kendrick A, Wray S. Drugs acting on the pregnant uterus. Obstet Gynaecol Reprod Med. 2010 Aug;20(8):241-247. doi: 10.1016/j.ogrm.2010.05.001.

  PMID: 24443652 BACKGROUND

• Brauer M, van Lunsen R, Burger M, Laan E. Motives for Vulvar Surgery of Women with Lichen Sclerosus. J Sex Med. 2015 Dec;12(12):2462-73. doi: 10.1111/jsm.13052. Epub 2015 Nov 27.

  PMID: 26610399 BACKGROUND

• Kreuter A, Kryvosheyeva Y, Terras S, Moritz R, Mollenhoff K, Altmeyer P, Scola N, Gambichler T. Association of autoimmune diseases with lichen sclerosus in 532 male and female patients. Acta Derm Venereol. 2013 Mar 27;93(2):238-41. doi: 10.2340/00015555-1512.

  PMID: 23224274 BACKGROUND

• Mazzola RF, Mazzola IC. The fascinating history of fat grafting. J Craniofac Surg. 2013 Jul;24(4):1069-71. doi: 10.1097/SCS.0b013e318292c447. No abstract available.

  PMID: 23851740 BACKGROUND

MeSH Terms

Conditions

Vulvar Lichen Sclerosus

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Patricia Gutierrez Ontalvilla

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2019
• First Posted: May 23, 2019
• Study Start: September 6, 2017
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: June 11, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)