A Double-Blinded, Randomized, Placebo-Controlled Pilot Study of the Safety and Efficacy of Myobloc (Botulinum Toxin Type B)-Purified Neurotoxin Complex for the Treatment of Crow's Feet: A Double-Blinded, Placebo-Controlled Trial

Abstract

Crow's feet develop with age and are one of the earliest signs of the normal aging process. Botulinum toxin type A, approved by the Food and Drug Administration for the treatment of glabellar wrinkles in April 2002, has been used off-label to treat facial wrinkles since 1981. Botulinum toxin type B (BTX-B, Myobloc) was Food and Drug Administration-approved for use in cervical dystonia in the United States in December 2000 and has subsequently been used in an off-label indication to treat facial wrinkles. There are sparse data in the literature evaluating the safety and efficacy of BTX-B for the treatment of facial wrinkles. In this pilot study, participants with moderate or severe crow's feet wrinkles were treated with Myobloc versus placebo. The duration of correction and side effect profile are reported.

Pilot study of the safety and efficacy of Myobloc™ (botulinum toxin type B) for treatment of axillary hyperhidrosis

“…Myobloc™ (botulinum toxin type B) effect ranged from 2.2 to 8.1 months, and 50% of the participants experienced sweating cessation for at least 4.6 months. The duration of action observed in this study is longer than those seen in studies using Myobloc™ (botulinum toxin type B) for wrinkle correction 10,11 . It is unknown at this time why this increased longevity would occurs, but it has been observed with the use of Botox® (botulinum toxin type A) as well 12 …”

Photoaging: Mechanisms and repair

“…197 In a pilot study it was shown to be effective in the correction of crow's feet and was well tolerated. 152 However, its use in the treatment of facial wrinkles has not yet been approved by the Food and Drug Administration. 152 Soft tissue augmentation Soft tissue augmentation, or ''fillers,'' are designed to address the subcutaneous atrophy that accompanies senescence.…”

“…152 However, its use in the treatment of facial wrinkles has not yet been approved by the Food and Drug Administration. 152 Soft tissue augmentation Soft tissue augmentation, or ''fillers,'' are designed to address the subcutaneous atrophy that accompanies senescence. Fillers have been used to treat fine lines and sallowness in photoaging, but have a greater market in intrinsically aged skin and for other cosmetic purposes.…”

Treating glabellar lines with botulinum toxin type A-hemagglutinin complex: A review of the science, the clinical data, and patient satisfaction

“…Clinically important biologic activity, particularly in the cosmetic arena, is limited primarily to the type A serotype, although a type B formulation is approved in several countries for treating cervical dystonia 21,22. Although botulinum toxin type B has been studied for cosmetic use, it generally elicits more pain upon injection and has been found to have a faster onset but shorter duration of action than the type A serotype 17,18,23–25. Therefore this review will be restricted to products containing botulinum toxin type A.…”