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Effectiveness and Safety Evaluation of Embella (Deoxycholic Acid, by Espad Pharmed Co.) in Management of Submental Fat

NCT06509438 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-19

Study results available
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Summary

Submental fat (SMF) is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid with the brand name KYBELLA® was approved by the American FDA for treatment of submental fat. The purpose of this study is to evaluate the safety and effectiveness of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition.

Research Objectives

Primary objective:

Effectiveness and safety of Embella® in reducing submental fat

Secondary objective:

Effectiveness assessment of Embella® in improving SMF grading Effectiveness assessment of Embella® in reducing submental fat diameter

Conditions

  • Submental Fullness

Interventions

DEVICE

Embella (Deoxycholic acid, produced by Espad Pharmed Co.)

2 milliliters of Embella injectable solution containing 20 milligrams of deoxycholic acid

Sponsors & Collaborators

  • Espad Pharmed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-10
Primary Completion
2024-01-01
Completion
2024-01-01

Countries

  • Iran

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06509438 on ClinicalTrials.gov