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Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01014871
Recruitment Status : Completed
First Posted : November 17, 2009
Results First Posted : April 5, 2012
Last Update Posted : April 20, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Single-centre, controlled, randomized, evaluator-blinded, bilateral (split-face) comparison study in subjects with moderate to severe forehead wrinkles.

One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.


Condition or disease Intervention/treatment Phase
Wrinkles Drug: Botulinum Toxin Type A - Azzalure Drug: Botulinum Toxin Type A - Vistabel Phase 2

Detailed Description:
There are two formulations of BoNT-A available: Botox®/Vistabel®, Allergan and Dysport®/Azzalure®, Ipsen - Galderma. These formulations behave distinctly in different ways electrophysiologically and clinically and results obtained with one formulation cannot be extrapolated to the other. There are only few clinical research directly comparing the two formulations in the treatment of forehead lines.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection
Study Start Date : July 2009
Primary Completion Date : April 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
intra-individual comparison Drug: Botulinum Toxin Type A - Azzalure
One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.
Drug: Botulinum Toxin Type A - Vistabel
One botulinum toxin type A will be injected in one side of the forehead and the other one will be injected in the other side of the forehead at Baseline. Allocation of each BoNT-A to each side of the forehead will be randomized.


Outcome Measures

Primary Outcome Measures :
  1. Severity of the Forehead Wrinkles by the Evaluator at Maximum Contraction and at Rest Using the Forehead Wrinkles Severity Scale (0 to 3) at Each Study Visit and for Each Side of the Forehead [ Time Frame: 5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5 ]
    Bilateral comparison of forehead wrinkle severity score at rest and at maximum contraction measured by Forehead Wrinkles Severity Scale (0 to 3) at each study visit (Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5)and for each side.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female Subjects of any race, from 18 to 65 years old
  2. Moderate to severe horizontal forehead wrinkles at maximum contraction (2-3 on the Forehead Wrinkles Severity Scale) on both sides of the forehead
  3. Negative urine pregnancy test at the Baseline visit for Subjects of childbearing potential

Exclusion Criteria:

  1. Subjects with a washout period for procedure(s)/treatment(s) on the forehead less than:

    • Retinoid, microdermabrasion, or prescription level glycolic acid treatments 2 weeks
    • Non-ablative light treatments (e.g. Intense Pulsed Light, light-emitting diodes) 1 month
    • Ablative skin resurfacing
    • Non-ablative dermal treatment for skin tightening (e.g. radio-frequency treatments) 6 months
    • Treatment with a BoNT-A 12 months
    • Soft tissue augmentation (e.g. biodegradable products as collagen or hyaluronic acid preparations) 24 months
  2. Subjects who undergone a surgical facelift;
  3. Permanent or semi-permanent dermal fillers in the forehead area;
  4. Known allergy or hypersensitivity to any botulinum toxin or any component of BoNT-A (1) and/or BoNT-A (2) (see package inserts);
  5. Concurrent use of treatments that affect neuromuscular transmission, such as curare-like depolarizing agents, lincosamides, polymyxins, anticholinesterases affecting the striated muscle and aminoglycoside antibiotics;
  6. Pregnant women, nursing mothers, or women who are planning pregnancy during the study;
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01014871


Locations
Germany
La Charité Hospital
Berlin, Germany
Sponsors and Collaborators
Galderma
Investigators
Principal Investigator: Pr Rzany, MD La Charité Hospital, Berlin, Germany
More Information

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01014871     History of Changes
Other Study ID Numbers: RD.03.SPR.29081
First Posted: November 17, 2009    Key Record Dates
Results First Posted: April 5, 2012
Last Update Posted: April 20, 2012
Last Verified: April 2012

Keywords provided by Galderma:
Forehead Wrinkles Toxin

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents