Efficacy and Tolerability Assessment of Deoxycholic Acid Injectable Solution for Reduction of Submental Fat Among the Iranian Population.

BACKGROUND

The purpose of this study was the safety and efficacy assessment of Embella (a deoxycholic acid injectable solution, manufactured by Espad Pharmed Daru Company), for the reduction of unwanted submental fat in Iranian patients.

METHODS

Twenty patients were included in this before-and-after study. One to three subcutaneous injections of maximum 2 ml of Embella containing 20 mg of deoxycholic acid were performed monthly. Assessments included the severity of submental fat using validated Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and diameter of submental fat, before injection, and 4 and 12 weeks after the last one. Patient satisfaction was evaluated using a visual analogue scale, and adverse events were reported.

RESULTS

At least one-grade improvement on the CR-SMFRS was seen in 79% and 62.5% at weeks 4 and 12 after the last injection. A significant decrease was observed in the median CR-SMFRS at weeks 4 and 12 (p-values<0.001 & 0.004). The median diameter of SMF decreased significantly from 1.85 cm to 1.4 and 1.45 cm at weeks 4 and 12 (p-values<0.001). The mean satisfaction scores were 7.63 and 7.43 out of 10. Adverse effects were mild to moderate and included tenderness, pain, swelling, and numbness at the injection site as well as globus sensation and cough which lasted between 2 days and 2 weeks and completely resolved at week 4.

CONCLUSIONS

Embella injectable solution was shown to be an effective way to reduce unwanted submental fat, and related adverse events were limited to mild and moderate temporary symptoms.

LEVEL OF EVIDENCE II

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