EUCTR2018-004696-12-IT
Active, not recruiting
Phase 1
Clinical, Instrumental and Histological evaluation of the combined use of Onabotulinumtoxin A and hyaluronic acid fillers in patients with facial paralysis - Onabotulinumtoxin A and hyaluronic acid fillers in the treatment of facial paralysis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- hemifacial paralysis (3 to 6 of the House-Brackmann scale)
- Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA
- Enrollment
- 70
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-Adult patients (18\-65\) with hemifacial paralysis from 3 to 6 on the House\-Brackmann scale, never treated with HA and BTX injection will be included in the study.
- •\-Signed informed consent.
- •\-Women of childbearing potential will only be included in the study if uptaking the following highly effective birth control measures: Women of childbearing potential will only be included in the study if uptaking the following highly effective birth control measures: \- Combined hormonal contraception associated with inhibition of ovulation (Oral, Transdermal, Intravaginal), \- Progesteron\-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable), \- Intrauterine devices, \- Intrauterine hormone\-releasing system, \- Bilateral tubal occlusion, \- vasectomized partner, \- Sexual abstinence
- •\- Patients will be included after a negative highly sensitive pregnancy test (blood test)
- •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 70
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •\-Hypersensitivity to any component of the products used
- •\-Diabetes, systemic diseases, coronary artery disease, acute\-chronic hepatitis C, autoimmune diseases and / or other diseases involving poor general health, clotting problem. Peripheric neuro\-muscolars disorders, amyotrophic lateral sclerosis (ALS).
- •\-Pregnant or lactating
- •\-Patients \<18 years and \>65 years old
Outcomes
Primary Outcomes
Not specified
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