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. 2025 Sep;49(17):4982-4988.
doi: 10.1007/s00266-025-04973-y. Epub 2025 Jun 2.

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

Taraneh Yazdanparast  1 , Mansour Nassiri Kashani  1 , Aniseh Samadi  1 , Araz Sabzvari  2 , Hamidreza Kafi  3 , Fatemeh Amiri  1 , Alireza Firooz  4
Affiliations

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

Taraneh Yazdanparast et al. Aesthetic Plast Surg. 2025 Sep.

Abstract

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: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Keywords: Deoxycholic acid; SMF; Submental fat.

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Conflict of interest statement

Declarations. Conflict of Interest: Araz Sabzvari is a member of CinnaGen medical biotechnology research center, which collaborates with universities and researchers all over the world with regards to research and development of medications and health issues. Hamidreza Kafi is the head of the medical department of Orchid Pharmed Company which is in collaboration with Espad Pharmed Daru Company with respect to conducting clinical trials. The other authors declare no conflict of interest. Ethics Approval: Institutional Review Board Approval was obtained (ethic code: IR.TUMS.TIPS.REC.1401.102) and written informed consent was taken from each patient. The study has been performed in accordance with the ethical standards in the Declaration of Helsinki.

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