Randomized Double-Blind Clinical Trial of Subcutaneously Injected Deoxycholate Versus a Phosphatidylcholine-Deoxycholate Combination for the Reduction of Submental Fat

Abstract

Under the conditions employed, injections of deoxycholate or phosphatidylcholine/deoxycholate into the submental fat produced minimal aesthetic improvement overall. No apparent differences in efficacy or adverse events were observed with the inclusion of phosphatidylcholine. Enhanced neck profiles in several subjects demonstrate a proof of concept that warrants further study utilizing a validated, submental profile grading scale and methods to optimize dose and technique.

Injectable treatments for fat and cellulite

“…Additional experiments have corroborated the lytic effects of DC on adipocytes in vivo and in vitro [49,50]. This laboratory and animal data has been validated through human studies that demonstrate comparable fat-reducing effects when either DC or PC/DC are injected into lipomas [40,31,44], abdominal [2,29], submental [3], and hip fat [2,3,29,40,41,30].…”

“…Two relatively recently conducted, IRB-approved prospective, randomized, double-blind clinical trials with compounded PC/DC and DC alone in submental fat [3] (Figure 4.3) and hips [30] and have substantiated the beneficial clinical effects of these medication observed in prior case series and retrospective studies. The indications, technique, safety profile, and so-called "standards of practice" (a paradox in light of its unregulated use) of PC/DC or Lipodissolve techniques therapy have been reviewed [2,3,35]. However, all of these reports utilize non-pharmaceutical grade (non-cGMP medication) DC derived from bovine sources, using anecdotal, nonstandardized techniques.…”

“…(formerly American Lipodissolve, St. Louis, MO), popularized a chain of treatment centers that used compounded medications of PC and DC based loosely on the original Lipostabil formulation. Compounded formulations generally consists of 5% PC combined with 4.2-4.75% DC [2,3,5] or 1-5% DC alone [2,3,[28][29][30][31]. At times, collagenase or lipolytic agents (i.e., caffeine, isoproterenol, yohimbine) were added to purportedly [18] augment fat reduction.…”

“…In an effort to identify what effects, if any, PC had on the lytic activity of DC, Bentow et al [55] found that in the presence of PC, almost 10 times more DC was required to lyse adipocytes, and that there is a threefold reduction in the area of fat necrosis as compared to when DC was used alone (Figure 4.8). These results may be a consequence of DC and PC spontaneously forming detergent/phospholipid aggregates called micelles [47,51]; while unbound DC is capable of lysing fat tissue, it is reasonable to assume that PC/DC micelles have no or minimal lytic capacity [3,55]. Rather than "protective," PC inhibits the desirable fat-reducing effects of DC.…”

“…Subcutaneous injections that reduce adipose tissue have been most frequently referred to as injection lipolysis, phosphatidylcholine/deoxycholate (PC/DC), Lipodissolve ® , and mesotherapy [1][2][3][4][5]. These terms are outdated and associated with controversial, unregulated treatments.…”