Evaluation of the combined use of Onabotulinumtoxin A and hyaluronic acid fillers in patients with facial paralysis

Phase 1

• Conditions: hemifacial paralysis (3 to 6 of the House-Brackmann scale); MedDRA version: 20.1Level: LLTClassification code 10016060Term: Facial palsySystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004696-12-IT
• Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-24
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 70

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

Study & Design

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