moderate to severe glabellar frown lines MedDRA version: 12.1 Level: LLT Classification code 10052609 Term: Glabellar frown lines
Conditions
Interventions
Trade Name: Vistabel
Pharmaceutical Form: Powder for injection*
Other descriptive name: Botulinum toxin type A
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration numb
Sponsors
Dermatologikum Hamburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Moderate to severe glabellar frown lines at rest (grade 2 to 3 on the FWS) as assessed by the investigator according to the FWS Female and male subjects between 18 to 65 years in good general health A subject of childbearing potential agrees to use one of the following contraceptive methods for the duration of the study: oStrict abstinence (exception: male partner with a vasectomy for at least 3 months prior to study entry is allowed) oCombined oral, implanted or injectable contraceptives on a stable dose for at least 3 months prior to study entrance oIntrauterine device (IUD) inserted for at least 1 month prior to study entrance Willingness to adhere to the study visit schedule, concomitant therapy prohibitions, treatment regimen and study procedures described in the protocol 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior treatment with Botulinum toxin within the last 6 months in the glabellar area Prior treatment with non permanent filler in the glabellar area within the last 12 months Any prior surgery affecting the glabellar area Permanent filler or any other permanent implants in the glabellar area Any planned cosmetic procedure (e.g. facelift, resurfacing (laser, photomodulation, IPL, radio frequency, dermabrasion, chemical peel or other ablative or non-ablative procedures) in the glabellar area during the course of the study Marked facial asymmetry or ptosis of eyelid and/or eyebrow A medical condition that may put the subject at increased risk with exposure to Botulinum toxin type A (Vistabel®) including but not limited to myasthenia gravis, Eaton-Lambert Syndrome, amyotrophic lateral sclerosis or any other neuromuscular dysfunction Any disease or medical condition that in the investigators opinion may put the subject at general risk and therefore would prevent participation in the clinical trial (including but not limited to cardiovasclar diseases, arrhythmia etc.) Subjects with an active inflammation, or active infection, cancerous or pre-cancerous lesion, or unhealed wound in the glabellar area Subjects with a history of an autoimmune disease or under immunosuppressive therapy or therapy used to decrease the body’s immune response History of facial nerve palsy History of narrow-angle glaucoma History of dysphagia, respiratory or speech disorders History of bleeding disorders Administration of anti-platelet or other medication with anticoagulant effect (e.g. acetylsalicylic acid, phenprocoumon, heparin injections, clopidogrel or others) Administration of agents such as aminoglycoside antibiotics that might interfere with the neuromuscular function Intake of drugs that might induce the productions of antibodies against acethycholine receptors (e.g. D-Penicillamin) Intake of drugs that might antagonize the onset of paralysis activity of botulinum toxins (such as the aminoquinolines chloroquine and hydroxyl-chloroquine) Subjects with a history of anaphylaxis or multiple severe allergies Subjects with a history of allergies or other side effects to lidocaine (or any amide-based anesthetic), hyaluronic acid products, Gram-positive bacterial protein, or other components of the study compound Subjects with a history of excessive scarring (e.g., hypertrophic scarring and keloid formulations) and pigmentation disorders Pregnancy, nursing or planning of pregnancy during the trial period or no usage of appropriate methods of contraception by females of childbearing potential Subjects who are – in the opinion of the investigator – unreliable, and/or non-compliant, and/or who present with any condition or treatment that may interfere with the conduct of the trial (e.g. psychiatric problems, evidence of drug or alcohol abuse) Participation in any other clinical trial within 30 days prior or during this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives are a.) to demonstrate the superiority of a single Botulinum toxin injection in combination with hyaluronic acid compared to treatment with hyaluronic acid alone with respect to prolonging the filler persistence within 4 months and b.) to demonstrate the superiority of repeated Botulinum toxin injections over single injection in combination with hyaluronic acid with respect to prolonging the filler persistence within 16 months. This is accomplished by comparison of response rates defined as the proportion of subjects with an improvement of one or more points on the Facial Wrinkle Scale (FWS).;Secondary Objective: The secondary objectives are to evaluate the efficacy of repeated and single treatments with Botulinum toxin (Vistabel®) treatment in combination with a hyaluronic acid (Juvéderm Ultra® 2) in subjects with glabellar frown lines compared to subjects with sole hyaluronic acid treatment as assessed by FWS, Physician’s Global Assessment, Subject’s Assessment of Satisfaction and subject's evaluation regarding the cosmetic outcome. Furthermore, safety and tolerability will be assessed by the severity, nature and frequency of AEs/SAEs and their relationship to the treatment, vital signs and the Physician’s Assessment of Tolerability. ;Primary end point(s): The primary endpoints are the response rates at rest at visit 4 and visit 7. A subject is defined to be a responder if the score of FWS improved at least one point between baseline (visit 1) and visit 4 and 7 respectively. | — |
Countries
Germany
Outcome results
None listed