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Botulinum toxin A (BTX-A) injection is the most popular cosmetic procedure in the U.S. The main medical limitations of BTX-A treatment include the need for injection and the resultant bruising. In this randomized, double-blind, repeat-dose, placebo-controlled, manufacturer-sponsored study, a topical BTX-A preparation (RT001) was applied under occlusion for 30 minutes to the crow's feet of 19 subjects, and placebo ointment was applied to the crow's feet of another 17 subjects. The treatments were repeated at 4 weeks. The degree of improvement was assessed in patients at rest on a 5-point wrinkle scale at 4 and 8 weeks after the first treatment.
At 4 and 8 weeks, 95% of RT001 subjects had at least a 1-point improvement in their wrinkle score, compared with only 15% of placebo subjects. Improvement of at least 2 points was noted in 29% of RT001 recipients at 4 weeks and in 50% of RT001 recipients at 8 weeks, compared with none of the placebo recipients. On self-ratings at 8 weeks, 84% of the RT001-treated subjects and 41% of the placebo-treated subjects rated their crow's feet to be improved. All comparisons were statistically significant. There were no treatment-related adverse events.
Brandt F et al. Efficacy and safety evaluation of a novel botulinum toxin topical gel for the treatment of moderate to severe lateral canthal lines. Dermatol Surg 2010 Dec; 36:2111 . (http://dx.doi.org/10.1111/j.1524-4725.2010.01711.x)
Comment
Topical BTX-A produced a significant therapeutic benefit for crow's feet. Whether it would be effective in areas of thicker skin and deeper muscles, such as the glabella or glabrous skin, remains to be seen. If this preparation receives FDA clearance, it may make BTX-A treatment accessible to patients who do not like needles or the associated discomfort. It could dramatically change the way BTX-A treatment is delivered, certainly moving it from the dermatologist's office and possibly even from under physician supervision. If not used correctly, however, very large doses of BTX-A could be delivered with adverse consequences or undesired therapeutic effects.