Randomized, parallel controlled study with routine clinical practice to evaluate the efficacy and tolerability of PRFC ENDORET® in the treatment of frontal fibrosing alopecia

Phase 1

• Conditions: • 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.; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2021-000865-33-ES
• Lead Sponsor: INSTITUTO DE INVESTIGACIÓN SANITARIA BIOARABA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-23
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 74

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified