Lipoma is a relatively common, slow-growing mesenchymal neoplasm originating from adipose tissue. Patients seek treatment for lipomas for various reasons, such as concerns about their growth and spread, aesthetic issues, or worries about the compressive effects of the lipoma. Lipomas are typically removed surgically through excision, which can have complications including bleeding, infection, scarring, and recurrence. Other mentioned treatment methods include liposuction, laser, and medicinal approaches. Purified synthetic deoxycholic acid has been introduced as the first pharmacological intervention approved by the FDA for the reduction of submental fat. Deoxycholic acid is a type of bile acid that, due to its ability to cause non-selective cell lysis and disruption of adipocyte membranes (adipocytolysis), leads to emulsification of fat in the intestine. This is an interventional (pre-post), single-arm, and open-label study to evaluate the efficacy and safety of Embella (Deoxycholic acid, produced by Espad Pharmed Co.) for the management of superficial lipomas.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
0.1 mL or 0.15 mL of a 10 mg/mL deoxycholic acid solution will be injected into every 1\*1 cm2 of the lipoma using an insulin syringe with a 1cm needle attached (the max volume of injection is 2 cc in each treatment session).
Orchid Pharmed, Medical Department
Tehran, Tehran Province, Iran
COMPLETEDRazi hospital
Tehran, Iran
RECRUITINGPercentage of calculated volume change of lipoma in participants
Percentage of calculated volume change from baseline to week 16 based on ultrasound evaluation in participants
Time frame: Baseline and week 16
Percentage of lipoma size change in participants
Percentage of lipoma size change from baseline to week 16 based on both ultrasound evaluation and objective evaluation (using flexible meter) in participants
Time frame: Baseline and week 16
Percentage of participant with lipoma size change more than 50%
Percentage of participant with size change more than 50% from baseline to week 16
Time frame: Baseline and week 16
Score of patient satisfaction
The score is evaluated by the answers of two questions: 1. How satisfied are you with the result of your injections? The scales are from 1 to 5, 1 indicating very dissatisfied, and 5 indicating very satisfied. 2. Knowing what you know now, how likely is it that you would choose this method again for your initial problem? The scales are: 1 indicating very likely, 3 indicating somewhat likely, and 5 indicating unlikely.
Time frame: Week 16
Percentage of participants requiring touch-up injection
Percentage of participants requiring touch-up injection (week 4 and week 8)
Time frame: Week 4 and week 8
Percentage of participants requiring surgical removal
Percentage of participants requiring surgical removal in 4 months after injections
Time frame: Week 16
Number of injections needed to achieve favorable result
Number of injections needed to achieve favorable result
Time frame: Week 16
The change in diameter of lipoma compared to baseline
The change in diameter of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
Time frame: Baseline, week 4, and week 8
The change in volume of lipoma compared to baseline
The change in volume of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
Time frame: Baseline, week 4, and week 8
The change in depth of lipoma compared to baseline
The change in depth of lipoma compared to baseline (week 4 and 8) based on ultrasound evaluation
Time frame: Baseline, week 4, and week 8
Safety assessment by evaluation of the severity of adverse events (AEs)
The severity of AEs is assessed at all visits, based on the physician's judgment.
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Safety assessment by evaluation of the seriousness of adverse events (AEs)
The seriousness of AEs is assessed at all visits, in accordance with the International Council for Harmonization (ICH-E2B) guidelines.
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
Safety assessment by evaluation of causality of adverse events (AEs)
The causality of AEs is assessed at all visits, based on World Health Organization (WHO) criteria.
Time frame: Screening visit, Visit 1 (Day 0), Visit 2 (week 4), Visit 3 (week 8), Visit 4 (week 16)
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