ATX-101 for reduction of submental fat: A phase III randomized controlled trial

Humphrey, Shannon; Sykes, Jonathan M.; Kantor, Jonathan; Bertucci, Vince; Walker, Patricia S.; Lee, Daniel R.; Lizzul, Paul F.; Gross, Todd M.; Beddingfield, Frederick C.

doi:10.1016/j.jaad.2016.04.028

Cited by 90 publications

(103 citation statements)

References 10 publications

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“…Based on this study, DC was suggested to be the principal component acting on the reduction of adipose tissue [12]. ATX-101, an injectable form of DC, was recently approved for submental fat reduction [17]. Consistent with this, our present study also showed that DC has a slightly stronger effect on the decrease of 3T3L1 preadipocyte viability (Fig 3A).…”

Section: Discussionsupporting

confidence: 88%

“…However, safety is the most important criterion for application as a therapeutic agent. DC injections have been associated with many adverse events including pain, edema, numbness, and swelling, although these were transient and restricted to the injected sites [17]. Furthermore, patients who received DC injections complained of pain more so than those treated with the PPC/DC formula [13].…”

Section: Discussionmentioning

confidence: 99%

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Selective effect of phosphatidylcholine on the lysis of adipocytes

et al. 2017

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Obesity, a serious health risk factor, is often associated with depression and negatively affects many aspects of life. Injection of a formula comprising phosphatidylcholine (PPC) and deoxycholate (DC) has emerged as an alternative to liposuction in the reduction of local fat deposits. However, the formula component mainly responsible for this effect and the mechanism behind the actions of the components with respect to fat reduction are unknown. Here, we investigate the specific effects of PPC and DC on adipocyte viability. When exposed to PPC or DC, 3T3L1 preadipocytes and differentiated adipocytes showed dose dependent decrease in cell viability. Interestingly, while DC mediated cell death was non-specific to both preadipocytes and adipocytes, PPC specifically induced a decrease in mature adipocyte viability, but had less effect on preadipocytes. Injection of PPC and DC into inguinal fat pads caused reduction in size. PPC injections preferentially decreased gene expression in mature adipocytes, while a strong inflammatory response was elicited by DC injection. In line with the decreased adipocyte viability, exposure of differentiated adipocytes to PPC resulted in triglyceride release, with a minimal effect on free fatty acids release, suggesting that its fat-reducing effect mediated mainly through the induction of adipocyte cell death rather than lipolysis. Taken together, it appears that PPC specifically affects adipocytes, and has less effect on preadipocyte viability. It can therefore be a promising agent to selectively reduce adipose tissue mass.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Selective effect of phosphatidylcholine on the lysis of adipocytes

et al. 2017

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“…[25–28, 31–34] In 2015, sodium deoxycholate (SD) was approved by the FDA to reduce the unwanted submental fat, a very different compound from those previously available. [35–37] SD acts like a detergent, causing adipolysis (or adipocytolysis) when injected directly into the area with extra fat tissue. [36, 38] SD lyses the adipocyte’s membrane, which is deficient in cell associated proteins, resulting in necrosis.…”

Section: Introductionmentioning

confidence: 99%

Total control of fat cells from adipogenesis to apoptosis using a xanthene analog

Tung

Han

2017

PLoS ONE

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Overcrowded adipocytes secrete excess adipokines and cytokines under stress, which results in a deregulated metabolism. This negative response to stress increases the possibility of obesity and several of its associated diseases, such as cancer and atherosclerosis. Therefore, a reduction in the number of adipocytes may be a rational strategy to relieve the undesired expansion of adipose tissue. A newly synthesized xanthene analog, MI-401, was found to have two distinct effects on the regulation of the adipocyte’s life cycle. MI-401 efficiently down regulated the expression of transcription factors, PPARγ and C/EBPα, and lipogenesis proteins, FAS and FABP4. This down regulation resulted in the inhibition of adipogenesis. Without newly differentiated adipocytes, the total number of adipocytes will not increase. In addition to this inhibitory effect, MI-401 was able to actively kill mature adipocytes. It specifically triggered apoptosis in adipocytes at low micro molar concentration and spared preadipocytes and fibroblasts. These dual functionalities make MI-401 an effective agent in the regulation of the birth and death of adipocytes.

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“…Several phase III, multicenter, randomized, placebo‐controlled, double‐blinded clinical trials with >1,700 patients have demonstrated the dose‐dependent efficacy of ATX‐101 (Table ). Adverse events were very common but transient and localized to the treatment area such as injection pain, swelling, bruising, numbness, and induration (Ascher et al, ; Dunican & Patel, ; Humphrey et al, ; Jones, Carruthers, et al, ; Rzany et al, ).…”

Section: Injection Lipolysis With Atx‐101mentioning

confidence: 99%

“…ATX-101 for submental contouring; randomized, placebo-controlled trials (cClinician-and pPatient-rReported SMF rRating sScales -CPRSMFRS) Point improvement in 59.2% (1 mg/cm 2 ) and 65.3% (2 mg/cm 2 ) versus 23.0% (placebo)Rzany et al (2014) NCT01294644360 ≥1-Point improvement in 58.3% (1 mg/cm 2 ) and 62.3% (2 mg/cm 2 ) versus 34.5% (placebo)Ascher et al (2014) REFINE-1 (NCT01542034) 506 ≥1-Point improvement in 70.0 versus 18.6% (placebo) REFINE-2 (NCT01546142) 516 ≥1-Point improvement in 66.5 versus 22.2% (placebo)Humphrey et al (2016) …”

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confidence: 99%

Aesthetic dermatology: What's new, what's true?

Wollina

Brzeziński

2018

Dermatologic Therapy

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Aesthetic dermatology (AD) is a rapidly growing subspecialty of dermatology. The acceptance of AD in scientific community and the society is associated with its competence, efficiency, and seriousness. This review highlights some recent developments toward new tools, techniques, and understanding in the field of AD. Analyzing the specific needs of patients and assessing the effect by objective measurements is important for further progress. For long time ignored, white adipose tissue has gained increasing interest in biology and rejuvenation. Characterization of dermal and subcutaneous white adipose tissue has made progress. The interaction of hyaluronic acid and calcium hydroxyl apatite (CaHA) fillers with adipocytes could be responsible for clinical efficacy. New developments of oral collagen treatment and highly diluted CaHA to contour the body outside the face will be discussed. Submental contouring using purified desoxycholic acid is another new development.

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ATX-101 for reduction of submental fat: A phase III randomized controlled trial

Cited by 90 publications

References 10 publications

Selective effect of phosphatidylcholine on the lysis of adipocytes

Selective effect of phosphatidylcholine on the lysis of adipocytes

Total control of fat cells from adipogenesis to apoptosis using a xanthene analog

Aesthetic dermatology: What's new, what's true?

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