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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

November 16, 2009
April 17, 2012
July 2009
April 2010   (final data collection date for primary outcome measure)
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.
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 (for a maximum of 10 visits) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01014871 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles
Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Wrinkles
  • 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.
intra-individual comparison
Interventions:
  • Drug: Botulinum Toxin Type A - Azzalure
  • Drug: Botulinum Toxin Type A - Vistabel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
May 2010
April 2010   (final data collection date for primary outcome measure)

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;
Female
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01014871
RD.03.SPR.29081
No
Galderma
Galderma
Not Provided
Principal Investigator: Pr Rzany, MD La Charité Hospital, Berlin, Germany
Galderma
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP