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
About this trial
This is an interventional treatment trial for Lichen Sclerosus of Vulva
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
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
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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