NCT03961126

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

Pilot Study of Vulvar Lichen Sclerosus (VLS) Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma (PRP).

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Instituto de Investigacion Sanitaria La Fe · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Lichen Sclerosus

Interventions

Type	Name	Description
DRUG	Injection of autologous fatty tissue associated with autologous platelet-rich plasma.	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	Corticosteroids (clobetasol 0.05%)	Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.

Timeline

• Start date: 2017-09-06
• Primary completion: 2019-12-12
• Completion: 2019-12-12
• First posted: 2019-05-23
• Last updated: 2020-06-11

Locations

1 site across 1 country: Spain