Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.
Condition: Vulvar Lichen Sclerosus
MeSH terms: Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Injection of autologous fatty tissue associated with autologous platelet-rich plasma.; Corticosteroids (clobetasol 0.05%)
Intervention type(s): Drug; Drug
Intervention description(s): 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.; Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.
Other intervention name(s): Experimental; Control
Intervention MeSH terms: Clobetasol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vulvar Lichen Sclerosus; Autologous Platelet-rich Plasma (PRP)