Clinical trial NCT05364515: Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Lichen Sclerosus of Vulva
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2022-05-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Evolution of quality of life measured by Skindex-29 index
timeFrame: 6 months
measure: Evolution of quality of life measured by Skindex-29 index
timeFrame: 8 months
Secondary outcomes:
measure: Evolution of quality of life measured by Skindex-29 index
timeFrame: 1 and 3 months
measure: Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar lichen sclerosus (CSS)
timeFrame: 1, 3, 6 and 8 months
measure: Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS)
timeFrame: 1, 3, 6 and 8 months
measure: Evolution of the improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I)
timeFrame: 1, 3, 6 and 8 months
measure: Evolution of clinical improvement at 1, 3, 6 and 8 months through the investigator's global assessment (IGA)
timeFrame: 1, 3, 6 and 8 months
measure: Frequency of recurrences at 6 and 8 months of treatment
timeFrame: 6 and 8 months
measure: Frequency of complications
timeFrame: 1, 3, 6 and 8 months
measure: Platelet concentration
timeFrame: 0 months
measure: Platelet recovery
timeFrame: 0 months
measure: Presence of leukocyte
timeFrame: 0 months
Other outcomes:
Locations:
Study officials:
References: