Botox research studies
Botox research abstracts. All four of these studies refer to the cosmetic use of botulinium nerotoxin type A for the temporary remediation of facial wrinkles. I offer them for those readers who like to draw their own conclusions.
Botox research abstract #1: Patient-reported outcomes with botulinum neurotoxin type A.
by Carruthers A, Carruthers J. from the Department of Dermatology and Skin Science, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Journal Cosmetic Laser Therapy. 2007;9 Suppl 1:32-7. Clinical trials establishing the efficacy of botulinum neurotoxin type A historically have included as outcomes investigator assessments and general patient global assessments of treatment. However, these outcomes are of limited value in determining the specific benefits desired by patients who seek facial rejuvenation.To address this issue, several patient-reported outcomes measures have been developed and utilized in clinical trials of botulinum neurotoxin type A (specifically, the BOTOX Cosmetic brand). The outcomes include the Self-Perception of Age (SPA) measure and the Facial Line Outcomes (FLO) questionnaire. On the FLO questionnaire, patients rate the degree to which their facial lines bother them; make them look older than they would like; prevent them from having a smooth facial appearance; and make them look tired, stressed, or angry when that is not how they feel. Several clinical trials have demonstrated significant improvements in these outcomes from baseline and versus placebo for the treatment of multiple upper facial lines as well as for treating the glabella as a single region. These outcomes data help in understanding patient objectives and motivations, establishing a treatment plan, and ensuring patient satisfaction. Clinicians can use the SPA measure for all patients to help show the value of treatment. END of first Botox research abstract.
Botox Research Abstract #2 Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport) for the treatment of wrinkles in the glabella and the central forehead region.
by Rzany B, Ascher B, Fratila A, Monheit GD, Talarico S, Sterry W. Division of Evidence Based Medicine, Klinik für Dermatologie, Venerologie und Allergologie, Charité Universitätsmedizin, Berlin, Germany. Arch Dermatol. 2006 Mar;142(3):320-6.OBJECTIVE: To investigate the efficacy and safety of 2 injection site patterns (3- and 5-injection patterns [30 and 50 U]) of botulinum toxin A (Dysport; Ipsen Pharma, Ettlingen, Germany), in the treatment of glabellar and central forehead wrinkles.DESIGN: Multicenter, double-blind, placebo-controlled, randomized, 16-week trial.SETTING: Twenty-three German dermatologic centers.PATIENTS: Two hundred twenty-one patients with moderate or severe glabellar wrinkles when frowning maximally.Intervention Centers were randomly assigned to the 3-injection site pattern (3 injections of 10 U of botulinum toxin A or placebo) or 5-injection site pattern (5 injections of 10 U of botulinum toxin A or placebo). All centers used 3 sites in the procerus and corrugator muscles; the 2 additional sites were approximately 1-cm cranial from the corrugator sites.MAIN OUTCOME MEASURE: Wrinkle severity was graded by 4 independent experts blinded to the treatment received using digital photographs and a standardized clinical scale (range, 0 [no wrinkles] to 3 [severe wrinkles]). A reduction of at least 1 point between weeks 0 and 4 was considered a therapeutic success (responder).RESULT: One hundred ten patients (73 receiving botulinum toxin A vs 37 receiving placebo) received 3 injections; 111 patients (73 receiving botulinum toxin A vs 38 receiving placebo) received 5 injections. After 4 weeks, the proportions of responders were 86.1% vs 18.9% and 86.3% vs 7.9%, respectively (P<.001 for both). No major adverse effects were observed.CONCLUSIONS: The 3 central injection sites are essential for the treatment of glabellar wrinkles. The 2 additional injection sites in the forehead region, targeting the frontalis muscle, did not significantly improve efficacy. END of Botox research abstract #2
Botox Research Abstract #3. Double-blind, placebo-controlled study of the safety and efficacy of botulinum toxin type A for patients with glabellar lines.
by Carruthers JD, Lowe NJ, Menter MA, Gibson J, Eadie N; Botox Glabellar Lines II Study Group. Department of Ophthalmology, University of British Columbia, Vancouver, Canada. Plast Reconstr Surg. 2003 Sep 15;112(4):1089-98.The objective of this study was to evaluate the efficacy and safety of botulinum toxin type A for the treatment of glabellar lines. Patients with moderate or severe glabellar lines at maximal frown received intramuscular injections of placebo or 20 U of botulinum toxin type A (Botox; Allergan, Inc., Irvine, Calif.) distributed among five injection sites (one in the procerus muscle and two in each corrugator supercilii). Follow-up assessments were performed at 7, 30, 60, 90, and 120 days after injections. Efficacy measures were the physician’s rating of glabellar line severity at maximal frown and at rest (none, mild, moderate, or severe) and the patient’s global assessment of changes in glabellar lines, from +4 (100 percent better) to -4 (100 percent worse). A total of 273 patients were enrolled (botulinum toxin, 202 patients; placebo, 71 patients).All except five patients (botulinum toxin, two patients; placebo, three patients) completed the study. For the physician’s rating at maximal frown, the responder rate (percentage of patients with severity ratings of none or mild in follow-up evaluations) for the botulinum toxin group peaked at 77 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). For the patient’s assessment, the responder rate (percentage of patients with scores of +2 or more) for the botulinum toxin group peaked at 89 percent at day 30 and was significantly greater than that for the placebo group at every follow-up visit (p < 0.001). Rates of adverse events were similar for the two groups. The only adverse event with an incidence of >/=5 percent was headache (botulinum toxin, 11 percent; placebo, 20 percent). The incidence of blepharoptosis was 1 percent for the botulinum toxin group. Botulinum toxin type A was remarkably safe and effective in reducing glabellar lines. END of Botox research abstract #3
Botox Research Abstract #4. Cosmetic use of botulinum toxin type A in the elderly. Cheng CM.
Department of Clinical Pharmacy, University of California, San Francisco, Clin Interv Aging. 2007;2(1):81-3.Botulinum toxin type A injections are one of the most popular cosmetic procedures for diminishing the appearance of facial lines caused by habitual facial muscle contractions. Although the manufacturer’s labeling recommends botulinum toxin only for the treatment of glabellar lines among adults younger than 65 years of age, there is widespread use of the toxin for other cosmetic purposes and for patients who may be older than 65. Evidence-based safety and efficacy data on botulinum toxin use in elderly patients is limited. However, given the age-related skin changes and multifactorial causes of wrinkles in the elderly, as well as the higher risk for potential side effects due to concomitant diseases and medications, a careful risk-benefit assessment should precede the decision to use botulinum toxin in the elderly patient.END of Botox Research abstract list.