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.

Study Overview

• Status: Completed
• Conditions: Wrinkles
• Intervention / Treatment: Drug: Botulinum Toxin Type A - Azzalure; Drug: Botulinum Toxin Type A - Vistabel

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • La Charité Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	5 months : Baseline, Days 1, 2, 3, 7, 10, 14, 30, Months 4 and 5

Collaborators and Investigators

• Sponsor: Galderma R&D
• Investigators: Principal Investigator: Pr Rzany, MD, La Charité Hospital, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: November 16, 2009
• First Submitted That Met QC Criteria: November 16, 2009
• First Posted (Estimate): November 17, 2009

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: Forehead Wrinkles Toxin
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
• Other Study ID Numbers: RD.03.SPR.29081

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No