Products

Azzalure

Azzalure Pack ShotProduct Summary

Azzalure®, botulinum toxin type A, has been available in the U.K. since the early 1990s as the brand name Dysport®, which has licences for various indications in 67 countries worldwide, including the United Kingdom and many European markets.

It gained approval for cosmetic use in the UK in early 2009 and is marketed for this indication, with dosing specific to treat glabellar (frown) lines,  under the brand name Azzalure®.

It is manufactured by the French company Ipsen and commercialised by Galderma.

 

Generic name

Clostridium botulinum toxin (type) A haemagglutinin neurotoxin complex. (125 Speywood units per vial).

 

How is it manufactured?

Azzalure® is made from purified type - A neurotoxin produced by the bacteria Clostridium botulinum.

 

How does it work?

It temporarily prevents the release of acetycholine from sympathetic nerve terminals.

 

Licenced status

Prescription only medicine

 

Who can administer the drug?

It should be used by trained members of the medical profession only.  

 

Licenced UK indications

In March 2009, Azzalure® was granted a licence in the UK from the Medicines and Healthcare products Regulatory Agency (MHRA) for the "temporary improvement in the appearance of moderate to severe glabellar lines (vertical "frown" lines between the eyebrows) in adult women and men aged 65 and younger, when the severity of these lines has a psychological impact for the patient" . 

The approval was based on several clinical trials involving more than 2,600 patients.

 

Who should not be treated?

Individuals with a known hypersensitivity to any component of the formulation.

Patients who have generalised disorders of muscle activity (e.g. myasthenia gravis).

Patients where aminoglycoside antibiotics or spectinomycin are already being used or are likely to be used.

Patients who have bleeding disorders of any type.

Pregnant or lactating women.

Not recommended by the manufacturer for use in individuals under 18 years of age.

Treatment interval should not be more frequent than every three months as this can increase the risk of antibody formation.

 

Reported side effects associated with cosmetic use include

Bruising, swelling, irritation or bleeding at the site of injection, headache, and rarely eyelid ptosis or diplopia, and brow droop.

 

Clinical data

During the clinical development of Azzalure®, more than 2,600 patients were included in the different clinical trials.

In clinical studies, 1907 patients with moderate to severe glabellar lines have been treated at the recommended dose of 50 Speywood Units. Of these, 305 were treated with 50 units in two pivotal Phase III double-blind placebo-controlled studies and 1200 treated with 50 units in a long-term open-label repeated dose Phase III study. The remaining patients were treated in supportive and dose-ranging studies.

The median time to onset of response was 2 to 3 days following treatment, with the maximum effect observed at day thirty.

In both pivotal placebo-controlled phase III studies, Azzalure® injections significantly reduced the severity of glabellar lines for up to 4 months. The effect was still significant after 5 months in one of the two pivotal studies.

 

Costs

Most clinics and practitioners charge by area of the face treated. These areas are usually defined as crow’s feet, forehead lines, and glabellar lines (frown lines between the eyes).

Azzalure® is a registered trademark of Galderma.


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Azzalure Reviews

Overall Product Rating For Azzalure

Azzalure Reviews. Read and compare 5 patient reviews and ratings for Azzalure . See if others recommend this cosmetic procedure and think its value for money. Or write your own review below!

Overall satisfaction with Product

3 out of 5 based on 5 reviews

3 Star

Level of pain experienced with Product

2 Star

Satisfaction with results achieved

4 Star

Value for Money

3 Star

Azzalure  Reviewed by cath p on 26/09/2011

NO difference what so ever.. also muscle relazxing on one side of my face .
Recommended?
Thumbs Down

Overall satisfaction with product

1 out of 5

1 Star

Level of pain experienced with product

3 Star

Satisfaction with results achieved

1 Star

Value for Money

1 Star

Azzalure  Reviewed by Mark Bradford on 01/09/2011

lovely product
Recommended?
Thumbs Up

Overall satisfaction with product

4 out of 5

4 Star

Level of pain experienced with product

1 Star

Satisfaction with results achieved

4 Star

Value for Money

4 Star

Azzalure  Reviewed by Mark Bradford on 01/09/2011

lovely product
Recommended?
Thumbs Up

Overall satisfaction with product

4 out of 5

4 Star

Level of pain experienced with product

1 Star

Satisfaction with results achieved

4 Star

Value for Money

3 Star

Azzalure  Reviewed by Jen Hayden on 28/05/2011

Clients very pleased with product. Jen @ Pretty Machine Aesthetics
Recommended?
Thumbs Up

Overall satisfaction with product

4 out of 5

4 Star

Level of pain experienced with product

4 Star

Satisfaction with results achieved

4 Star

Value for Money

4 Star

Azzalure  Reviewed by Sally Tabrett on 15/03/2011

Excellant product with lasting results. Patients very pleased.
Recommended?
Thumbs Up

Overall satisfaction with product

4 out of 5

4 Star

Level of pain experienced with product

1 Star

Satisfaction with results achieved

5 Star

Value for Money

5 Star

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