Storing vials of reconstituted botulinum toxin A (Botox, Allergan) for four weeks after patient administration results in no detectable bacterial or fungal contamination, according to a new pilot study.

“Although findings of several studies indicated that reconstituted botulinum toxin A (BTX-A) retained efficacy during storage for several weeks, there was insufficient evidence that sterility was maintained for this duration. Regardless of potency, contamination remained a concern for physicians who treat patients with reconstituted BTX-A after the recommended period by the manufacturer,” the study’s lead author Teissy Osaki, M.D., and Ph.D. candidate at the division of ophthalmic plastic and reconstructive surgery, Federal University of São Paulo, São Paulo, Brazil, tells Cosmetic Surgery Times.

Dr. Osaki and colleagues evaluated the contents of 88 reconstituted vials of BTX-A after clinical administration of an aliquot and subsequent storage of the remaining contents under refrigeration for four weeks.

Research suggests the practice of storing and using reconstituted BTX-A is somewhat common.

“…an online survey of BTX-A utilization among members of the American Society for Dermatologic Surgery indicated that most physicians (68.6%) routinely store BTX-A for a longer period (more than one week after reconstitution) than the 24-hour period recommended by the manufacturer,” Dr. Osaki says.

But this study by no means supports the practice. The authors of the study do not recommend utilizing reconstituted BTX-A beyond the period indicated by the manufacturer, according to Dr. Osaki.

“Our study was a pilot study…,” Dr. Osaki says. “Future multicentric studies that evaluate a larger number of vials and other possible contaminants are needed, and the results of these additional future studies may support the storage of reconstituted BTX-A for longer than the period recommended by the manufacturer.”

Note: There were some errors in the published version and an erratum will be published in the next edition of Aesthetic Surgery Journal, according to Dr. Osaki.

Osaki T, Osaki MH, Osaki TH, Sant'Anna AE, Yu MC, Hofling-Lima AL. Absence of bacterial or fungal growth in vials of reconstituted botulinum toxin type A after storage. Aesthet Surg J. 2015 Feb;35(2):189-93. http://www.ncbi.nlm.nih.gov/pubmed/25717119

Sebum production after botulinum toxin A (Botox, Allergan) treatment for forehead rhytids positively correlates with the distance away from the injection point, according to a new study. Intramuscular botulinum type A injections notably reduce sebum production at injection sites, while increasing sebum production of the surrounding skin, according to the study published May in the Aesthetic Surgery Journal.

Chinese and Italian researchers studied 42 females receiving intramuscular botulinum toxin A injections for forehead rhytides, looking for sebum regulation and gradient surrounding injection sites. They compared two injection doses — two and four units — administered in five standard injection sites, and measured sebum production at baseline and post-treatment.

Researchers found botulinum toxin A treatment resulted in significant change to the sebum at the injection site of both groups, with a sebum gradient surrounding the injection point.

“The efficacy did not improve at higher injection doses, with the four-unit regimen generally not being more potent than the two-unit regimen,” they write.

Sebum production, however, went back to normal levels at the 16-week follow-up for both treatment groups. This suggests the higher four-unit dosage did not result in a longer duration until relapse than the two-unit dose. While sebum production was lower at the injection sites, it increased at a radius of 2.5 cm at the 2-, 4- and 8-week follow-ups, the researchers write.

Implications for Practice

Implications for Practice

What implication does this study have for practice? Plastic surgeon Robert Singer, M.D., of La Jolla, Calif., who was not an author of the study says questions remain and more research is needed. The finding that Botox decreases sebum production is not new and has been in the medical literature for years, he says.

“What the implications will be in the practical use, we’ll have to wait and see. It may play a role in some patients with recalcitrant acne, but, at this point, there are a lot of other modalities of treatment, topically, that may be effective,” Dr. Singer says. “[Botulinum toxin A] certainly has not been studied in teens, who have most of the acne. It’s an interesting finding. I wouldn’t think it’s going to play a main role in treatment right now.”

The fact that the neurotoxin also increased sebum production leads to more questions, according to the plastic surgeon.

“Are you just shifting the area of sebum production and potentially the acne?” wonders Dr. Singer.

However, these findings could suggest that botulinum toxin A might be a potential acne treatment down the road, he says.

Min P, Xi W, Grassetti L, et al. Sebum production alteration after botulinum toxin type A injections for the treatment of forehead rhytides: A prospective randomized double-blind dose-comparative clinical investigation. Aesthet Surg J. 2015 Mar 29.

A new pilot study suggests botulinum toxin A could help reduce pain and expedite expansions by relaxing the pectoralis major muscle in post-mastectomy tissue expander-based breast reconstruction.

“Immediate or delayed reconstruction cases can be plagued with pain from the direct pressure that the expander exerts onto the muscle.  The toxin in this case helps by relaxing the muscle and making the reconstructive period more tolerable, especially during the expansion phase,” the study’s lead author Allen Gabriel, M.D., associate clinical professor of plastic surgery, at Loma Linda University Medical Center, Loma Linda, Calif., tells Cosmetic Surgery Times.

Researchers studied 30 patients undergoing mastectomies with immediate expander or acellular dermal matrix reconstruction. Fifteen patients received 40 units of botulinum toxin A (Botox, Allergan; neurotoxin group) injected into each pectoralis major muscle through four serial injections. The remaining 15 patients received four serial injections of 0.9% sodium chloride (NaCl; placebo group).

Researchers followed the patients for more than a year, recording patient demographics, visual analog score, laterality, office visits, amount of expansion and number of times to full expansion, as well as the amount of required narcotics.

They found the two groups were similar in terms of age, laterality, expander size and complications. But patients receiving the neurotoxin had less pain compared with those in the placebo group. There was also a significant increase in the volume of expansion each visit in the botulinum toxin A group. And while patients in the two groups has similar narcotic usage in the three days after surgery, narcotic use dropped significantly in the neurotoxin group from days 7 to 45, compared to the placebo group.

“For some patients, the toxin can be injected into the pectoralis major with the use of ultrasound before or after surgery. In our study, the toxin was injected into the pectoralis major muscle during surgery by direct visualization,” Dr. Gabriel explains. “The principle of muscle relaxation can be utilized in any implant based surgical cases, where the pectoralis major is elevated. This applies to both reconstructive and cosmetic breast surgery cases.”

The researchers reported no neurotoxin-associated complications. The study was first published online March 30, 2015 in the Aesthetic Surgery Journal. 

Gabriel A, Champaneria MC, Maxwell GP. The efficacy of botulinum toxin a in post-mastectomy breast reconstruction: a pilot study. Aesthet Surg J. 2015 May;35(4):402-9.