Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) for the Treatment of Flank Fat

Inclusion criteria

• Having mild to moderate flank fat assessed by the investigator and sonography and/or caliper (≥2cm thickness of the fat tissue in posterior axillary lines at the level of ASIS)
• Signing informed consent by the subject
• Ability to follow study instructions and likely to complete all required visits
• Agreement to abstain from any treatment to the flank region, including botulinum toxins, hyaluronic acid fillers, cosmetic surgery, laser/light therapy, chemical peels, etc., during the study

Exclusion criteria

• Planning to change lifestyle within the projected duration of the trial
• History of liposuction surgery or laser lipolysis in the past 12 months or planning to have these procedures
• Significant weight reduction in the past 6 months or planning for weight reduction within the projected duration of the trial
• BMI > 30 kg/m2
• Waist circumference > 105 cm
• Uncontrolled systemic diseases
• Severe cardiovascular diseases
• Known allergy or sensitivity to the study medication or its components
• Females who are pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial
• Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study and for the duration of the study.
• Previous treatment to the flanks with hyaluronic acid fillers or semi-permanent filler in the past 12 months
• Use of any permanent filler materials or silicone in the flanks
• Subjects planning a cosmetic procedure in the treatment area during the study or with prior cosmetic procedures (i.e., surgery) in the treatment area or visible scars that may affect the evaluation
• Subjects with volume deficit due to trauma, abnormalities in adipose tissue related to immune-mediated diseases such as generalized lipodystrophy (e.g., juvenile dermatomyositis), partial lipodystrophy (e.g., Barraquer-Simons syndrome), inherited disease, or HIV-related disease
• Infection or dermatoses at the injection site
• Evidence of recent alcohol or drug abuse
• Medical and/or psychiatric problems that are severe enough to interfere with the study results
• Known bleeding disorder or receiving medication that will likely increase the risk of bleeding after injection
• Having hair that would interfere with evaluation and treatment of the flank area
• Being prone to develop hypertrophic scarring
• Having a history of anaphylaxis or allergy to lidocaine (or any amide-based anesthetics), hyaluronic acid products, or Streptococcal protein
• Having porphyria
• Having an active inflammation, infection, cancerous or precancerous lesion, or unhealed wound in the flank area
• Having a condition or being in a situation that, in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study