Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat.

BACKGROUND: The injectable adipocytolytic drug ATX-101 is the first nonsurgical treatment for the reduction of submental fat (SMF) to undergo comprehensive clinical evaluation. This study aimed to confirm the efficacy and safety of ATX-101 for SMF reduction through a post hoc pooled analysis of two large phase 3 studies. METHODS: Patients with unwanted SMF were randomized to receive 1 or 2 mg/cm(2) of ATX-101 or a placebo injected into their SMF during a maximum of four treatment sessions spaced approximately 28 days apart, with a 12-week follow-up period. The proportions of patients with reductions in SMF of one point or more on the Clinician-Reported SMF Rating Scale (CR-SMFRS) and the proportions of patients satisfied with the appearance of their face and chin [Subject Self-Rating Scale (SSRS) score ≥4] were reported overall and in subgroups. Other efficacy measures included improvements in the Patient-Reported SMF Rating Scale (PR-SMFRS), calliper measurements of SMF thickness, and assessment of skin laxity [Skin Laxity Rating Scale (SLRS)]. Adverse events and laboratory test results were recorded. RESULTS: Significantly greater proportions of the patients had improvements in clinician-reported measures (≥1-point improvement in CR-SMFRS: 58.8 and 63.8 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 28.6 % of the placebo recipients; p < 0.001 for both ATX-101 doses vs. placebo) and patient-reported measures (≥1-point improvement in PR-SMFRS: 60.0 and 63.1 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, vs. 34.3 % of the placebo recipients; p < 0.001 for both), analyzed alone or in combination, with ATX-101 versus placebo. These improvements correlated moderately with patient satisfaction regarding face and chin appearance (SSRS score ≥4: 60.8 and 65.4 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, vs. 29.0 % of the placebo recipients; p < 0.001 for both). In this study, ATX-101 was effective irrespective of gender, age, or body mass index. Reduction in SMF with ATX-101 was confirmed by calliper measurements (p < 0.001 for both doses vs. placebo) and generally did not lead to worsening of skin laxity (SLRS improved or was unchanged: 91.3 and 90.5 % of the patients who received ATX-101 1 and 2 mg/cm(2), respectively, and 91.6 % of the placebo recipients). Adverse events were mostly transient, mild to moderate in intensity, and localized to the treatment area. CONCLUSION: The findings show ATX-101 to be an effective and well-tolerated pharmacologic treatment for SMF reduction.

Iatrogenic full-thickness chemical burns from monochloracetic acid.

A case of iatrogenic full-thickness chemical burns from monochloroacetic acid (MCA) crystal application is described, followed by a brief review of the relevant literature and discussion of both local and systemic problems that may be encountered with absorption of this chemical. We believe this to be the first reported case of full-thickness burns in association with MCA. The degree of injury and systemic side effects encountered as a procedure complication highlights the importance of using this chemical with care in any clinical setting. In addition, an apparent predilection of MCA for the germinal matrix as found in this case may further complicate reconstructive options for associated injuries.

Coin and currency burn.

We describe a case of burns purposefully sustained in a patient performing a bizarre pub game while under the influence of alcohol. Full-thickness burns were sustained through contact with a 50-p UK currency coin essentially heated with burning paper. We discuss the nature and ease by which such burns can be sustained in the community and the increasing awareness of alcohol abuse as a factor in a significant proportion of such self-inflicted burns.