Comparison of Two Botulinum Toxins Type A on Forehead Wrinkles

Wrinkles Clinical Trial

Official title:

Intra-individual Comparison of the Efficacy of Two Botulinum Toxins Type A on Moderate to Severe Forehead Wrinkles After One Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014871
• Other study ID #: RD.03.SPR.29081
• Status: Completed
• Phase: Phase 2
• Start date: July 2009
• Est. completion date: May 2010

Study information

• Verified date: April 2012
• Source: Galderma R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• Wrinkles

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	La Charité Hospital	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Galderma R&D

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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