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Injection-site adverse events with Kybella easily managed
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Typical measures were effective at treating injection-site adverse events associated with Kybella treatment for submental fat, according to study results published in Dermatologic Surgery.
Researchers conducted the study between December 2013 and June 2014. They evaluated 84 patients, including 68 who were treated with Kybella (deoxycholic acid, Allergan), also known as ATX-101, and 15 who were treated with placebo.
The patients were randomized to four paradigm groups, in which either they received a cold pack application to the treatment area (paradigm 1), cold pack plus topical lidocaine and injectable lidocaine containing epinephrine (paradigm 2), all treatment of paradigm 2 plus loratadine and ibuprofen (paradigm 3), and all interventions of paradigm 3 and a chin strap (paradigm 4).
The Short-Form McGill Pain Questionnaire was used to measure quality of pain experienced by patients, and was administered immediately before treatment, after completion of the pain visual analog scale at 4 hours after treatment and on days 1, 2, 3, 7, 14, 21, 28 and 84 days after treatment.
Peak pain occurred within 1 to 5 minutes in patients treated with deoxycholic acid, with median values at time points in the mild range on a 100-mm pain visual analog scale.
By 15 minutes after treatment, pain ratings reduced substantially. Pain was characterized as “mild tenderness or mild achiness” at 4 hours after injection.
The treatment with topical and injectable lidocaine reduced median peak by 17% compared with cold treatment alone (paradigm 1). There was a total reduction in pain by 40% when ibuprofen and loratadine were added to the treatment.
Patients treated with deoxycholic acid in all paradigms had “modest” peak swelling/edema (mean values ≤ 1.7 on a 0-5 scale). Interventions, including ibuprofen, loratadine and using a chin strap, did not substantially mitigate swelling or edema. The bruising associated with deoxycholic acid was confined to the treatment area, with bruising was “modestly reduced by injectable lidocaine with epinephrine.”
“The results show that in most patients, post-treatment pain was mild at peak intensity, and described mostly as tender and achy by 4 hours,” the researchers wrote. “A combination of ice, topical lidocaine/injectable lidocaine with epinephrine, and ibuprofen/loratadine seemed to be most effective in the management of pain, whereas the inclusion of epinephrine mitigated bruising to a modest extent.
“These findings are suggestive that injection-site [adverse events] reported with ATX-101 treatment can be easily managed with typical methods used for management of common [adverse events] associated with facial injectables.” – by Bruce Thiel
Disclosure: Dover reports no relevant financial disclosures. Please see the full study for a list of the other researchers’ relevant financial disclosures.
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