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Botox Works, OTC Creams Do Not

So far, you can’t just rub the wrinkles away.

Attempting to ride on the coattails of botulinum toxin type A (Botox), manufacturers of several cosmeceuticals claim similar or even better efficacy. In this study sponsored by the manufacturer of Botox, 77 women randomly received Botox, placebo, or one of three topical creams for their moderate-to-severe glabellar rhytids. The studied agents were Botox, 20 units total; StriVectin-SD twice daily for 12 weeks; Wrinkle Relax (formerly Faux-Tox) twice daily for 12 weeks; HydroDerm twice daily for 12 weeks; and sterile saline injections. Glabellar wrinkle severity at rest and while frowning was assessed at baseline and at 4, 8, and 12 weeks by the patients and by an investigator blinded to treatment.

Clinician-rated mean severity of glabellar rhytids at maximum frown was significantly reduced relative to baseline at all follow-up visits among Botox recipients. The mean change from baseline was not significantly better than placebo for any topical treatment, except for Wrinkle Relax at the 12-week visit. The improvement over baseline in severity of glabellar lines at rest was also significant in the Botox group compared with any other treatment at all time points, except for Wrinkle Relax at 12 weeks. Of the Botox-treated subjects, 86% exhibited better than 50% improvement on a global change-in-appearance scale.

In self-assessments, most placebo and topical-treatment recipients reported either no improvement in appearance or a maximum of 25% improvement. Botox recipients reported significantly greater improvement in glabellar lines compared with placebo recipients. No significant changes were reported by the cream- or placebo-treated patients, except in one parameter at one time point for Wrinkle Relax recipients. Botox recipients reported more satisfaction than did recipients of any other treatment option. The only study-related side effects (red papules on the forehead and itchy rash on the extremities) developed in two recipients of StriVectin. In a follow-on, crossover, open-label study, all patients achieved a satisfactory improvement in their glabellar lines with Botox treatment.

Comment: As one might expect, unsubstantiated claims by cosmeceutical marketers regarding their products’ equivalence to Botox in improving wrinkles did not stand up to controlled assessment (bearing in mind that the study was funded by the manufacturer of Botox). The only cream that showed a hint of efficacy on wrinkles was Wrinkle Relax, which, after 12 weeks of use, seemed to show a mild effect. StriVectin contains 40 ingredients, Wrinkle Relax has 32, and HydroDerm has 18, including 5 parabens. With so much in the mix, it seems nearly impossible to sort out which, if any, ingredients have a clinical effect other than moisturizing skin or causing contact dermatitis. Of course, that may well be precisely what is intended.

— George J. Hruza, MD

Published in Journal Watch Dermatology May 9, 2006

Citation(s):

Beer KR. Comparative evaluation of the safety and efficacy of botulinum toxin type A and topical creams for treating moderate-to-severe glabellar rhytids. Dermatol Surg 2006 Feb; 32:184-92.

• Medline abstract (Free)

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