Proof-of-concept-study to Evaluate the Efficacy and Tolerability of Repeated Versus Single Treatment with Botulinum-Toxin (Vistabel®) Treatment in Combination with a Hyaluronic Acid (Juvederm-Ultra® 2) in Patients with Glabellar Frown Lines

• Conditions: moderate to severe glabellar frown lines; MedDRA version: 12.1Level: LLTClassification code 10052609Term: Glabellar frown lines

• Registration Number: EUCTR2010-020057-13-DE
• Lead Sponsor: Dermatologikum Hamburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-29
• Last Update Posted: 16 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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