The efficacy and safety of Deoxycholic acid injection in reduction of flank fat

Phase 4

• Conditions: Localized adiposity; Flank fat.

• Registration Number: IRCT20240416061507N1
• Lead Sponsor: Espad Pharmed Co

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Mild to moderate flank fat (clinically proven and based on caliper measurements and ultrasound criteria)
Ability to complete the study and follow instructions
Informed consent to participate in the study
Consent on not performing any other intervention in the flank area during the study period

Exclusion Criteria

Severe medical or psychological conditions that interfere with the study results
History of hypersensitivity to components of the product under study
Pregnancy and breastfeeding
History of previous flank fat treatment
BMI >??
Patients prone to intravascular volume reduction
Evidence of recent alcohol or drug abuse
History of bleeding disorders or recent consumption (less than 3 weeks) of thrombolytic drugs, anticoagulants, platelet inhibitors orNSAIDs
History of hypertrophic scarring
Infection, inflammation, dermatosis, unhealed wound, cancer or precancerous lesions at the injection site

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The percentage of flank fat reduction. Timepoint: The beginning of the study and week 6 and 12. Method of measurement: Using ultrasound and calipers.

Secondary Outcome Measures

Name	Time	Method
Incidence and seriousness of adverse event. Timepoint: week 6 and 12. Method of measurement: Examination by the medical team with a questionnaire.