• Patients diagnosed with fibrosing frontal alopecia (FFA) with an age greater than or equal to 18 years. • Patient not responding to previous treatments for at least 6 months. • Use of effective physical or pharmacological contraceptive measures • Free acceptance to participate in the trial, with the written informed consent of the volunteer.
Conditions
Interventions
Trade Name: PRFC-ENDORET
Product Name: PRFC ENDORET
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: PRGF-Endoret
Other descriptive name: Autologous platelet rich plasm
Sponsors
INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients diagnosed with fibrosing frontal alopecia (FFA) with an age greater than or equal to 18 years. • Patient not responding to previous treatments for at least 6 months. • Use of effective physical or pharmacological contraceptive measures • Free acceptance to participate in the trial, with the written informed consent of the volunteer. 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 74 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • Hematological or bleeding disorders. • Diagnosed platelet dysfunction. • Use of anticoagulant therapy or non-steroidal anti-inflammatory drugs in the 5 days prior to the extraction of the blood sample. • Cancer and / or treatment with chemotherapy and / or radiotherapy. • Topical or intralesional use of corticosteroids in the previous 4 weeks. • Severe or multiple allergy to medications. • Allergy or intolerance to any component of the study products (including peanuts and / or soybeans) • Hypersensitivity to calcium chloride and / or calcium citrate. • Patients who are immunosuppressed or who have received immunosuppressive treatment in the previous 12 weeks. • Presence of untreated thyroid disease. • Local or systemic infections. • Infectious processes, folliculitis, facial herpes or uncontrolled pigmentation disorders. • Patients undergoing chemical peeling, laser or any other type of facial treatment during the previous 6 months. • Any medical or psychiatric condition that makes it difficult, according to clinical judgment, to participate in the study. • Being participating in another research study. • Patients with unattainable expectations. • Pregnancy and / or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of PRFC ENDORET® as an adjunct treatment to routine clinical practice (topical solution of clobetasol) in the improvement of skin lesions of AFF through the change in the score of the “FFASS-Frontal Fibrosing Alopecia Severity Score;Secondary Objective: To evaluate the efficacy of the PRFC ENDORET® as an adjunct treatment to routine clinical practice (clobetasol topical solution) in improving the quality of life of patients through the change in the score of the Hair Specific Skindex questionnaire29. Evaluate the patient's impression of improvement through the patient's global impression of improvement scale. (PGI-I) Assess the clinician's impression of improvement through the global clinical improvement scale (CGI-GI) Evaluate the safety and tolerability of the PRFC ENDORET® as an adjunct treatment to routine clinical practice by recording adverse effects and guaranteeing the safety of the study patients.;Primary end point(s): To evaluate the efficacy of PRFC ENDORET® as an adjunct treatment to routine clinical practice (topical solution of clobetasol) in the improvement of AFF skin lesions through the change in the score of the “FFASS-Frontal Fibrosing Alopecia Severity Score”. ;Timepoint(s) of evaluation of this end point: FFASS will be assessed at 4 and 12 weeks after the start of the treatment and at 4 and 12 weeks after the end of the treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To evaluate the efficacy of the PRFC ENDORET® as an adjunct treatment to routine clinical practice (clobetasol topical solution) in improving the quality of life of patients through the change in the score of the Hair Specific Skindex questionnaire29. Evaluate the patient's impression of improvement through the patient's global impression of improvement scale. (PGI-I) Assess the clinician's impression of improvement through the global clinical improvement scale (CGI-GI) Evaluate the safety and tolerability of the PRFC ENDORET® as an adjunct treatment to routine clinical practice by recording adverse effects and guaranteeing the safety of the study patients.;Timepoint(s) of evaluation of this end point: Hair Specific Skindex questionnaire29 will be assessed at 4 and 12 weeks after the start of the treatment and at 4 and 12 weeks after the end of the treatment. Patient's global impression of improvement scale. (PGI-I) will be assessed at 12 weeks after the end of the treatment. Global clinical improvement scale (CGI-GI) will be assessed at 4 and 12 weeks after the start of the treatment and at 4 and 12 weeks after the end of the treatment. Evaluate the safety and tolerability along all the study. | — |
Countries
Spain
Contacts
Public ContactBIOARABA
INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA
Outcome results
None listed