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    Clinical Trial Results:
    Pilot study of vulval lichen sclerosus treatment by adipose tissue associated with autologous platelet-rich plasma

    Summary
    EudraCT number
    		 2016-003952-63
    Trial protocol
    		 ES  
    Global end of trial date
    12 Dec 2020

    Results information
    Results version number
    		 v1(current)
    This version publication date
    12 Feb 2022
    First version publication date
    12 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    LIQUENIA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto de Investigación Sanitaria La Fe de Valencia
    Sponsor organisation address
    Avenida Fernando Abril Martorell, Torre 106 A 7planta, 46026 València, , Valencia, Spain,
    Public contact
    Jose Maria Millan Salvador, Instituto de Investigación Sanitaria La Fe, investigacion_clinica@iislafe.es
    Scientific contact
    Jose Maria Millan Salvador, Instituto de Investigación Sanitaria La Fe, investigacion_clinica@iislafe.es
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    02 Dec 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Dec 2020
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Dec 2020
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Demonstrate the improvement in the elasticity of the fibrosis plaques of patients affected by vulval lichen sclerosus after two infiltrations of fat tissue and autologous platelet-rich plasma.
    Protection of trial subjects
    The reference study was conducted in Spain under the legal framework of Royal Decree 1090/2015. It has been performed in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996). In addition, the study has been conducted in accordance with the protocol, good clinical practice (GCP) in accordance with the guidelines of the international conference on harmonization (ICH) and regulatory requirements for participating institutions. An appropriately performed informed consent has been used, in compliance with GCP according to ICH guidelines and approved by the CEIm of the Hospital Universitario y Politécnico La Fe. Prior to inclusion of subjects in the study, a copy of the CEIm-approved informed consent has been reviewed with the prospective participant, signed and dated. The investigator has provided a copy of each subject's signed informed consent form and has retained a copy in the subject's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 Sep 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    19
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 • Start of patient inclusion: September 2017 • Completion of inclusion of patients: March 2018 • Patient follow-up time: 12 months. • Expected completion date of the last patient included: March 2019.

    Pre-assignment
    Screening details
    		 • Adult women between 18 and 70 years of age. • Patients with a clear clinical and/or histological diagnosis of lichen sclerosus (LE). • Moderate or severe involvement of the disease at the genital level. • Patients who have received topical treatment for at least three months with 0.05% clobetasol propionate. • Prior signed informed consent

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 maintenance treatment of topical corticosteroid therapy (clobetasol 0.05%) to be administered as per usual clinical practice.
    Arm type
    		 Normal treatment

    Investigational medicinal product name
    clobetasol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Cream
    Routes of administration
    Topical use
    Dosage and administration details
    Reference treatment, dose and mode of administration: Clobetasol propionate 0.05%. Route of administration: topical Dosage: 1 application per day, twice a week.

    Arm title
    		 Treatment group
    Arm description
    		 2 infiltrations separated by three months will be applied by intra and subdermal injection in each vulvar half with identical amount of treatment composed of autologous fat tissue (10cc) enriched with autologous platelet-rich plasma (2cc).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Autologous adipose tissue
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Injection
    Dosage and administration details
    Intra and subdermal injection in each vulvar half of 20cc of autologous fatty tissue + 4cc of autologous platelet-rich plasma.

    Number of subjects in period 1
    		Control Treatment group
    Started
    10
    10
    Completed
    10
    9
    Not completed
    0
    1
         discontinued intervention
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Control
    Reporting group description
    		 maintenance treatment of topical corticosteroid therapy (clobetasol 0.05%) to be administered as per usual clinical practice.

    Reporting group title
    Treatment group
    Reporting group description
    		 2 infiltrations separated by three months will be applied by intra and subdermal injection in each vulvar half with identical amount of treatment composed of autologous fat tissue (10cc) enriched with autologous platelet-rich plasma (2cc).

    Reporting group values
    		 Control Treatment group Total
    Number of subjects
    		 10 10 20
    Age categorical
    Adult women between 18 and 70 years of age.
    Units: Subjects
        Adults 18-70 years
    		 10 10 20
    Gender categorical
    Units: Subjects
        Female
    		 10 10 20

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 maintenance treatment of topical corticosteroid therapy (clobetasol 0.05%) to be administered as per usual clinical practice.

    Reporting group title
    Treatment group
    Reporting group description
    		 2 infiltrations separated by three months will be applied by intra and subdermal injection in each vulvar half with identical amount of treatment composed of autologous fat tissue (10cc) enriched with autologous platelet-rich plasma (2cc).

    Primary: Elasticity of the fibrotic plaques in the affected vulvar area

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    End point title
    		 Elasticity of the fibrotic plaques in the affected vulvar area
    End point description
    End point type
    Primary
    End point timeframe
    12 moths
    End point values
    		 Control Treatment group
    Number of subjects analysed
    10
    9
    Units: Number
    arithmetic mean (standard deviation)
        Baseline
    0.57 ( 0.19 )
    0.63 ( 0.12 )
        12 months
    0.65 ( 0.18 )
    0.68 ( 0.12 )
    Statistical analysis title
    		 T-Test
    Statistical analysis description
    Categorical variables were described as absolute counts and percentages, while continuous variables were described as means and standard deviations. The efficacy analysis was based on the per-protocol principle—defined as all the randomized patients without major protocol violations that met the inclusion criteria who received the scheduled study medication and completed the efficacy measurements both at baseline and at 12 months. The baseline characteristics of both groups were compared,
    Comparison groups
    Control v Treatment group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 -
    Variability estimate
    Standard deviation
    Notes
    [1] - For continuous variables, Student’s t tests were used for normal data or Mann–Whitney U tests were employed otherwise. Data symmetry was analyzed using the Shapiro–Wilk normality test. Mann–Whitney U tests were used for group comparisons. Histological changes were evaluated by using Wilcoxon matched-pairs signed-rank tests. All the statistical tests used to evaluate the treatment effects were 1-sided and were considered statistically significant when the P values were\0.05. All the stat

    Secondary: Pain

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    End point title
    		 Pain
    End point description
    End point type
    Secondary
    End point timeframe
    12 moths
    End point values
    		 Control Treatment group
    Number of subjects analysed
    10
    9
    Units: Number
    arithmetic mean (standard deviation)
        Baseline
    2.3 ( 3 )
    5.3 ( 3.9 )
        1 year
    3.6 ( 3.5 )
    1.3 ( 1.4 )
    Statistical analysis title
    		 t-Student
    Comparison groups
    Control v Treatment group
    Number of subjects included in analysis
    19
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.077
    Confidence interval
         level
    		 95%
         sides
    1-sided
         lower limit
    		 0
         upper limit
    		 -

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The investigator recorded in the CRD all the adverse events that occurred in the patients who participated in the clinical trial. AEs were followed up by the investigator and documented on the CRF up to 28 days after the end of the treatment period.
    Adverse event reporting additional description
    The SAEs were notified by the investigator to the sponsor when he became aware of it
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    24.1
    Reporting groups
    Reporting group title
    Control
    Reporting group description
    		 -

    Reporting group title
    Treatment
    Reporting group description
    		 -

    Serious adverse events
    		 Control Treatment
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Control Treatment
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    10 / 10 (100.00%)
    10 / 10 (100.00%)
    Investigations
    New diagnosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    Vascular disorders
    Trombidiasis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    40
    40
    Surgical and medical procedures
    Varicose vein
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    40
    40
    Nervous system disorders
    Headache
         subjects affected / exposed
    5 / 10 (50.00%)
    4 / 10 (40.00%)
         occurrences all number
    40
    40
    Skin and subcutaneous tissue disorders
    Vulvar Liche Sclerosis
         subjects affected / exposed
    3 / 10 (30.00%)
    0 / 10 (0.00%)
         occurrences all number
    40
    40
    Endocrine disorders
    Biliary cirrhosis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 10 (0.00%)
         occurrences all number
    40
    40
    Musculoskeletal and connective tissue disorders
    Low back pain
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    40
    40
    Arthralgia
         subjects affected / exposed
    2 / 10 (20.00%)
    1 / 10 (10.00%)
         occurrences all number
    40
    40
    Fracture
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 10 (0.00%)
         occurrences all number
    40
    40
    Infections and infestations
    Respiratory tract infection
         subjects affected / exposed
    5 / 10 (50.00%)
    2 / 10 (20.00%)
         occurrences all number
    7
    7
    Urinary tract infection
         subjects affected / exposed
    4 / 10 (40.00%)
    1 / 10 (10.00%)
         occurrences all number
    40
    40
    Gastrointestinal infection
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 10 (10.00%)
         occurrences all number
    40
    40

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/35048150
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