CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Injection of autologous fatty tissue associated with autologous platelet-rich plasma. +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03961126
NCT03961126Phase 2Completed
CompareCT.gov

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

Instituto de Investigacion Sanitaria La Fe·interventional·Posted May 23, 2019·Updated Jun 11, 2020

In Brief

A Phase 2 clinical trial evaluating Injection of autologous fatty tissue associated with autologous platelet-rich plasma. and Corticosteroids (clobetasol 0.05%) for Vulvar Lichen Sclerosus. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Lichen Sclerosus
CountriesSpain
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMay 23, 2019
Enrollment StartSep 6, 2017
Primary CompletionDec 12, 2019
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.1 years ago

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.

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.