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Dose-Ranging Study of Botulinum Toxin Type A in the Treatment of Glabellar Rhytids in Females

CARRUTHERS, ALASTAIR, MD*; CARRUTHERS, JEAN, MD; SAID, SAMIREH, MD*

ORIGINAL ARTICLE
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Objective To compare the efficacy, safety, and duration of effect of four doses of botulinum toxin type A in the treatment of glabellar rhytids in females.

Design Double-blind, randomized, parallel-group, dose-ranging trial followed by an open-label extension.

Setting Private dermatologic clinic.

Subjects Eighty female subjects with moderate to severe wrinkles at maximum frown entered the study. The first 40 subjects completing the double-blind phase entered the open-label extension.

Intervention Random administration of 10, 20, 30, or 40 U botulinum toxin type A in divided doses. Open-label trial: 30 U botulinum toxin type A at the same sites in divided doses.

Main Outcome Measurements Trained observer and subject assessments of wrinkle severity at maximum frown and repose using the Facial Wrinkle Scale (0 = none to 3 = severe), subject satisfaction, and adverse events. Follow-up monthly for up to 1 year postinjection.

Results Relapse rates and responder rates revealed benefits lasting 3 to 6 months or longer. Objectively, 10 U of botulinum toxin type A was significantly less effective than 20, 30, or 40 U. The relapse rate at 4 months was significantly higher in the 10 U group (83%) versus 40, 30, or 20 U (28%, 30%, and 33%, respectively). Subject satisfaction was high in all groups. Duration of effect and response rates were sustained during the open-label extension. Adverse effects were mild and infrequent.

Conclusion Twenty to 40 U botulinum toxin type A doses were significantly more effective at reducing glabellar lines than 10 U. Most subjects experienced benefits for 3 to 4 months; some subjects demonstrated effect for up to 12 months.

*Division of Dermatology and Department of Ophthalmology, University of British Columbia, Vancouver, British Columbia, Canada

Address correspondence and reprint requests to: Alastair Carruthers, MD, Division of Dermatology, University of British Columbia, 943 West Broadway, Suite 820, Vancouver, BC V5Z 4E1, or e-mail: alastair@carruthers.net.

THIS STUDY WAS FUNDED BY A GRANT FROM ALLERGAN, INC. ALASTAIR CARRUTHERS AND JEAN CARRUTHERS ARE ALLERGAN CONSULTANTS.

© 2005 by the American Society for Dermatologic Surgery, Inc.
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