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Arch Dermatol. 2006 Mar;142(3):320-6.

Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport) for the treatment of wrinkles in the glabella and the central forehead region.

Author information

  • 1Division of Evidence Based Medicine, Klinik für Dermatologie, Venerologie und Allergologie, Charité Universitätsmedizin, Campus Charité Mitte, Schumannstrasse 20/23, D-10117 Berlin, Germany. berthold.rzany@charite.de

Abstract

OBJECTIVE:

To investigate the efficacy and safety of 2 injection site patterns (3- and 5-injection patterns [30 and 50 U]) of botulinum toxin A (Dysport; Ipsen Pharma, Ettlingen, Germany), in the treatment of glabellar and central forehead wrinkles.

DESIGN:

Multicenter, double-blind, placebo-controlled, randomized, 16-week trial.

SETTING:

Twenty-three German dermatologic centers.

PATIENTS:

Two hundred twenty-one patients with moderate or severe glabellar wrinkles when frowning maximally. Intervention Centers were randomly assigned to the 3-injection site pattern (3 injections of 10 U of botulinum toxin A or placebo) or 5-injection site pattern (5 injections of 10 U of botulinum toxin A or placebo). All centers used 3 sites in the procerus and corrugator muscles; the 2 additional sites were approximately 1-cm cranial from the corrugator sites.

MAIN OUTCOME MEASURE:

Wrinkle severity was graded by 4 independent experts blinded to the treatment received using digital photographs and a standardized clinical scale (range, 0 [no wrinkles] to 3 [severe wrinkles]). A reduction of at least 1 point between weeks 0 and 4 was considered a therapeutic success (responder).

RESULT:

One hundred ten patients (73 receiving botulinum toxin A vs 37 receiving placebo) received 3 injections; 111 patients (73 receiving botulinum toxin A vs 38 receiving placebo) received 5 injections. After 4 weeks, the proportions of responders were 86.1% vs 18.9% and 86.3% vs 7.9%, respectively (P<.001 for both). No major adverse effects were observed.

CONCLUSIONS:

The 3 central injection sites are essential for the treatment of glabellar wrinkles. The 2 additional injection sites in the forehead region, targeting the frontalis muscle, did not significantly improve efficacy.

PMID:
16549707
DOI:
10.1001/archderm.142.3.320
[PubMed - indexed for MEDLINE]
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