A Two-Center, Open-Label, Randomized, Split-Face Study to Assess the Efficacy and Safety of One Versus Three Intradermal Injection Sites of AbobotulinumtoxinA in the Treatment of Lateral Periocular Rhytides

August 2013 | Volume 12 | Issue 8 | Original Article | 932 | Copyright © 2013

Sabrina G. Fabi MD,a Hema Sundaram MD,b Isabella Guiha BS,a and Mitchel P. Goldman MDa,

aGoldman, Butterwick, Fitzpatrick, Groff, and Fabi, Cosmetic Laser Dermatology, San Diego, CA
bSundaram Dermatology, Cosmetic and Laser Surgery, Rockvillle, Maryland and Fairfax, VA

Abstract

BACKGROUND: Lateral canthal rhytides partly result from repetitive muscular actions of the orbicularis oculi.
OBJECTIVE: To determine the efficacy of one versus three injection sites of AbobotulinumtoxinA (ABO) in the treatment of lateral canthal rhytides.
METHODS: This was a two-center, evaluator-masked, 120 day study in which 40 patients with moderate to severe hyperdynamic lateral canthal rhytides at maximal contracture were randomized to receive one injection of 36 Units of ABO into the middle of the lateral orbital rhytides on one side, with the contralateral side treated with the same total dose of ABO, divided into three intradermal injections of 12 Units each, along the lateral canthal area. A blinded evaluator assessed lateral orbital rhytides at rest and maximal contraction at baseline, 7, 42, 90, and 120 days post treatment. Standardized digital photography and subject self- assessment were performed at each visit.
RESULTS: No statistically significant difference was seen at any visit between sides treated with one injection and those treated with three injections in any evaluation category. There was no difference in adverse events between the two sides.
CONCLUSION: Sites treated with three injections of ABO showed no statistically significant difference from those treated with one injection.

J Drugs Dermatol. 2013;12(8):932-937.

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BACKGROUND

Noninvasive procedures with little to no downtime that offer significant improvement to the aging appearance of the skin and underlying musculature are often preferred to surgical procedures. Although no procedure is entirely risk-free, continued research is required to provide a safe and efficacious approach to aesthetic procedures for treating the aging face.

Although five factors have been identified that contribute to the appearance of the aging face,1 there are two anatomical units that most influence the appearance of facial rhytids: the skin and its underlying musculature. Many therapies have evolved to treat rhytids including resurfacing, topical preparations, soft tissue injectable fillers, and lastly, botulinum toxin.

Many studies have demonstrated the effect of botulinum toxin on facial rhytids produced by underlying coordinated muscle groups. Effects on the glabellar area, upper forehead, lower forehead, periocular and perinasal area are particularly well documented. Previous reports of ABO show effective relaxation of glabellar rhytids after injection2-7 and ABO has also been found to be efficacious in the cosmetic treatment of dynamic rhytides in the lateral ocular region.

ABO is generally well tolerated, although side effects may occur, such as temporary paralysis of adjacent muscle groups close to those injected, which may be due to local spread of toxin from the injection site and /or misplaced injections. Most side effects are of mild or moderate severity, and of limited duration. The most common adverse event (AE) seen following the therapeutic use of botulinum toxin for the treatment of blepharospasms is blepharoptosis. Some patients have reported diplopia or symptoms resulting from the spread of effect to mid-facial muscles. Other AEs reported were injection site reaction, skin rashes, influenza- like symptoms, dry eyes, tearing, bruising, and eyelid swelling. Reversible ophthalmoplegia has been reported after excessive dosing.

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