Vulvar Lichen Sclerosus et atrophicus
Conditions
Interventions
Product Name: PRGF
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: PRGF
Other descriptive name: PLATELET CONCENTRATE
Concentration unit: U unit(s)
Concentration type:
Sponsors
BTI I MAS D S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age> 18 years - Woman with symptoms associated with LEA confirmed with histological study - Spend 1 month without previous treatment in the affected area as a washing period - Availability of observation during the treatment period - Signature of the informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - Somatic disease in acute state - Infection in the area of ??intervention or active systemic infection - History of cancerous or precancerous lesions in the area of intervention - In active treatment with other local treatments in the intervention area - In active treatment with immunosuppressants and / or anticoagulants - History of allergies to blood derivatives - Previous diagnosis of coagulopathies - Regular and continued treatment with NSAIDs - Positive markers for HCV, AfHBs, HIV-I / II or TP - Pregnancy or women of childbearing potential not taking contraceptive measures - Lactating women - Treatment with monoclonal antibodies - Any inability to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Analyze the efficacy of PRGF® in the evolution of quality of life of patients with vulvar lichen sclerosus et atrophicus at six and eight months.;Secondary Objective: 1. Study the evolution of dermatological quality of life at 1 and 3 months. 2. Study the clinical evolution at 1, 3, 6 and 8 months. 3. Study the evolution of pain at 1, 3, 6 and 8 months. 4. Study the global impression of improvement at 1, 3, 6 and 8 months. 5. Characterization of blood hematological parameters and PRGF®. 6. Frequency of recurrences at 6 and 8 months of treatment. 7. Evaluate the safety of PRGF®.;Primary end point(s): Evolution of quality of life at 6 and 8 months measured through the Skindex-29 index: validated scale referring to dermatological diseases;Timepoint(s) of evaluation of this end point: 6 and 8 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Evolution of quality of life at 1 and 3 months measured by the Skindex-29 index: validated scale referring to dermatological diseases. 2. Evolution of response to treatment at 1, 3, 6 and 8 months through the clinical scale of vulvar sclerosus lichen (CSS): validated scale regarding the diagnosis and response to treatment in front of the LEA. 3. Evolution of pain at 1, 3, 6 and 8 months measured through the visual analog pain scale (VAS): validated scale referring to pain. 4. Evolution of improvement at 1, 3, 6 and 8 months through the patient's global impression (PGI-I): validated scale referring to the degree of improvement subjective of the patient. 5. Evolution of clinical improvement at 1, 3, 6 and 8 months through the researcher's global assessment (IGA): validated scale referring to degree of clinical improvement of the pathology observed by a clinical specialist. 6. Frequency of relapses at 6 and 8 months of treatment.;Timepoint(s) of evaluation of this end point: 1. 1 and 3 months 2. 1, 3, 6 and 8 months. 3. 1, 3, 6 and 8 months. 4. 1, 3, 6 and 8 months. 5. 1, 3, 6 and 8 months. 6. 6 and 8 months. | — |
Countries
Spain
Contacts
Public ContactClinical Trials Unit
BTI I MAS D
Outcome results
None listed