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Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva (PRGF)

Primary Purpose

Lichen Sclerosus of Vulva

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
PRGF
Clobetasol Propionate
Sponsored by
Fundación Eduardo Anitua
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lichen Sclerosus of Vulva

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Age >18 years
  • Woman with symptoms associated with LEA confirmed by histological study
  • Being 1 month without prior treatment in the affected area as a washing period
  • Availability of observation during the treatment period
  • Signature of the informed consent

Exclusion Criteria:

  • Acute somatic disease
  • Infection in the intervention area or active systemic infection
  • History of cancerous or precancerous lesions in the intervention area
  • In active treatment with other local treatments in the intervention area
  • Under active treatment with immunosuppressants and/or anticoagulants
  • History of allergies to blood derivatives
  • Previous diagnosis of coagulopathies
  • Regular and continuous treatment with NSAIDs
  • Positive markers for HCV, AfHBs, HIV-I/II or PT
  • Pregnancy or women of childbearing age not taking contraceptive measures
  • Lactating women
  • Treatment with monoclonal antibodies
  • Liver failure
  • Any inability to participate in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Conventional treatment

    PRGF

    Arm Description

    0.05% Clobetasol propionate

    0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month)

    Outcomes

    Primary Outcome Measures

    Evolution of quality of life measured by Skindex-29 index
    Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
    Evolution of quality of life measured by Skindex-29 index
    Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome

    Secondary Outcome Measures

    Evolution of quality of life measured by Skindex-29 index
    Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
    Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)
    Values: from 0 to 40. Lower scores mean a better outcome.
    Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)
    Values: from 0 to 40. Lower scores mean a better outcome.
    Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
    Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
    Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
    Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
    Frequency of recurrences at 6 and 8 months of treatment
    Frequency of recurrences at 6 and 8 months of treatment
    Frequency of complications
    Frequency of complications
    Platelet concentration
    Platelet concentration measurement in whole blood and PRGF fraction
    Platelet recovery
    Platelet enrichment (PRGF vs. whole blood)
    Presence of leukocyte
    % of leukocyte in PRGF fraction

    Full Information

    First Posted
    April 12, 2022
    Last Updated
    July 6, 2022
    Sponsor
    Fundación Eduardo Anitua
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05364515
    Brief Title
    Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
    Acronym
    PRGF
    Official Title
    Randomized Clinical Trial, Controlled to Conventional Treatment, to Evaluate the Efficacy of Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    October 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Fundación Eduardo Anitua

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment. Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lichen Sclerosus of Vulva

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conventional treatment
    Arm Type
    Active Comparator
    Arm Description
    0.05% Clobetasol propionate
    Arm Title
    PRGF
    Arm Type
    Experimental
    Arm Description
    0.05% Clobetasol propionate + PRGF PRGF: 4 infiltrations (first two months) + topical administration (from third month)
    Intervention Type
    Drug
    Intervention Name(s)
    PRGF
    Intervention Description
    Plasma Rich in Growth Factors (PRGF) is a mixture of proteins and growth factors obtained from the blood of the patient. Four PRGF infiltrations (two weeks between each infiltration). Then, application of topical PRGF serum (on alternate basis)
    Intervention Type
    Drug
    Intervention Name(s)
    Clobetasol Propionate
    Intervention Description
    0.05 propionate clobetasol: daily (first month), alternate (second moth), twice per week (from third month)
    Primary Outcome Measure Information:
    Title
    Evolution of quality of life measured by Skindex-29 index
    Description
    Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
    Time Frame
    6 months
    Title
    Evolution of quality of life measured by Skindex-29 index
    Description
    Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
    Time Frame
    8 months
    Secondary Outcome Measure Information:
    Title
    Evolution of quality of life measured by Skindex-29 index
    Description
    Quality of life in patients with cutaneous disease (Skindex-29 index). Values from 0 to 116. Lower scores mean a better outcome
    Time Frame
    1 and 3 months
    Title
    Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)
    Description
    Values: from 0 to 40. Lower scores mean a better outcome.
    Time Frame
    1, 3, 6 and 8 months
    Title
    Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)
    Description
    Values: from 0 to 40. Lower scores mean a better outcome.
    Time Frame
    1, 3, 6 and 8 months
    Title
    Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
    Description
    Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
    Time Frame
    1, 3, 6 and 8 months
    Title
    Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
    Description
    Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
    Time Frame
    1, 3, 6 and 8 months
    Title
    Frequency of recurrences at 6 and 8 months of treatment
    Description
    Frequency of recurrences at 6 and 8 months of treatment
    Time Frame
    6 and 8 months
    Title
    Frequency of complications
    Description
    Frequency of complications
    Time Frame
    1, 3, 6 and 8 months
    Title
    Platelet concentration
    Description
    Platelet concentration measurement in whole blood and PRGF fraction
    Time Frame
    0 months
    Title
    Platelet recovery
    Description
    Platelet enrichment (PRGF vs. whole blood)
    Time Frame
    0 months
    Title
    Presence of leukocyte
    Description
    % of leukocyte in PRGF fraction
    Time Frame
    0 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age >18 years Woman with symptoms associated with LEA confirmed by histological study Being 1 month without prior treatment in the affected area as a washing period Availability of observation during the treatment period Signature of the informed consent Exclusion Criteria: Acute somatic disease Infection in the intervention area or active systemic infection History of cancerous or precancerous lesions in the intervention area In active treatment with other local treatments in the intervention area Under active treatment with immunosuppressants and/or anticoagulants History of allergies to blood derivatives Previous diagnosis of coagulopathies Regular and continuous treatment with NSAIDs Positive markers for HCV, AfHBs, HIV-I/II or PT Pregnancy or women of childbearing age not taking contraceptive measures Lactating women Treatment with monoclonal antibodies Liver failure Any inability to participate in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mikel Allende, PhD
    Phone
    +34945160653
    Ext
    257
    Email
    mikel.allende@bti-implant.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva

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