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Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma
ClinicalTrials.gov Identifier:
NCT01014871
First received: November 16, 2009
Last updated: April 17, 2012
Last verified: April 2012
History of Changes
  Purpose

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 Intervention Phase
Wrinkles
 Drug: Botulinum Toxin Type A - Azzalure
Drug: Botulinum Toxin Type A - Vistabel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Botox
U.S. FDA Resources

Further study details as provided by Galderma:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Galderma
ClinicalTrials.gov Identifier: NCT01014871     History of Changes
Other Study ID Numbers: RD.03.SPR.29081
Study First Received: November 16, 2009
Results First Received: August 12, 2011
Last Updated: April 17, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Galderma:
Forehead Wrinkles Toxin

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013