Clinical trial NCT03961126: Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.
Official title: Pilot Study of Vulvar Lichen Sclerosus (VLS) Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma (PRP).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vulvar Lichen Sclerosus
Keywords: Vulvar Lichen Sclerosus
Autologous Platelet-rich Plasma (PRP)
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Randomized, prospective and unicentric study, in which the investigators evaluate patients with vulvar lichen sclerosus who undergo surgical treatment consisting of two separate infiltrations by intra and subdermal injection in each half vulvar of autologous fatty tissue associated with autologous platelet-rich plasma, in order to:

Main objective:

To estimate the population parameters of the study variables, as well as their variability, to be able to determine the sample size and statistical power for a future clinical trial whose main objective will be to demonstrate the efficacy of this treatment regarding the increase in the vulvar elasticity in patients with vulvar lichen sclerosus.

Secondary Objectives:

1. To evaluate if there is a structural improvement in the vulva areas treated at month, 3 months, 6 months and 12 months after the first infiltration and at 3 and 9 months after the second infiltration.
2. To analysis the improvement of fibrosis and inflammation 6 months after the first infiltration and 3 months after the second infiltration.
3. To study if there is an improvement in symptoms at month, 3 months, 6 months, 12 months after the first infiltration and at 3 months and 9 months after the second infiltration.
4. To examine whether there is an improvement in the quality of patients life.
5. Subsequent use of clinical and pain assessment scale in this study and in another lichen sclerosus vulvar studies with a greater number of patients.
6. To evaluate the adverse events derived from the treatment during the first year after the first infiltration through its registration in the CRD.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Vulvar elasticity measured by the cutometer-dualmpa®
timeFrame: Month 1 after first infiltration.
measure: Vulvar elasticity measured by the cutometer-dualmpa®
timeFrame: Month 3 after first infiltration.
measure: Vulvar elasticity measured by the cutometer-dualmpa®
timeFrame: Month 6 after first infiltration.
measure: Vulvar elasticity measured by the cutometer-dualmpa®
timeFrame: Year 1 after first infiltration.
measure: Vulvar elasticity measured by the cutometer-dualmpa®
timeFrame: Month 3 after second infiltration.
measure: Vulvar elasticity measured by the cutometer-dualmpa®
timeFrame: Month 9 after second infiltration.
Secondary outcomes:
measure: Histological improvement measured by the scale for histological assessment.
timeFrame: Month 6
measure: Improvement in the quality of patients' life measured by skindex-29 questionnaire quality of life.
timeFrame: Month 1, Month 3, Month 6, Year 1
measure: Improvement in the clinical symptoms by clinical assessment scale.
timeFrame: Month 1, Month 3, Month 6, Year 1
measure: Improvement in the pruritus measured by 4D Pruritus Scale.
timeFrame: Month 1, Month 3, Month 6, Year 1
measure: Improvement in the pain measured by Pain Scale.
timeFrame: Month 1, Month 3, Month 6, Year 1
measure: Improvement in sexual performance by Sexual Functioning Index (SFI)
timeFrame: Month 1, Month 3, Month 6, Year 1
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
affiliation: Hospital La Fe
name: Patricia Gutierrez Ontalvilla
role: PRINCIPAL_INVESTIGATOR
References:
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