Background
Deoxycholic acid (DCA) is commonly used to treat moderate-to-severe submental fat, while it has been suggested for use in other areas.
Purpose
The purpose is to assess Deoxycholic acid’s safety and efficacy in decreasing fat in the hypogastric region.
Materials and Procedures
An open-label, an interventional pilot study was undertaken that was prospective, longitudinal, nonrandomized, and prospective. Deoxycholic acid was applied transcutaneously to the upper right, upper left, lower right, and lower left hypogastric zones. Fat thickness was measured using three-dimensional scanning, ultrasonography, and calipers. The primary endpoint safety was evaluated using laboratory testing and the prevalence of unfavorable occurrences.
Introduction
Unwanted upper inner thigh fat is a common aesthetic problem. Liposuction, cryolipolysis (CoolSculpting, Allergan, Irvine, CA), and non-invasive energy-based fat removal technologies are currently available therapy alternatives; each has a distinct safety and efficacy profile. Liposuction is an invasive procedure with a small but significant risk of nerve injury, bleeding, fat embolization, and anesthesia-related complications. Non-invasive cryo-lipolysis can cause aches and pains for up to two weeks, as well as temporary redness, swelling, or bruising and, in rare cases, paradoxical adipose hyperplasia.
Submental fat is treated with FDA-approved injectable deoxycholic acid (Kybella, Allergan, Irvine, CA). It has yet to be approved by the FDA for treating upper inner thigh fat. Phosphatidylcholine is a fat-emulsifying soybean lecithin that increases solubility by adding deoxycholic acid, a secondary bile acid when it was first developed as an injectable treatment for adipocyte lysis. During the study, it was discovered that deoxycholic acid, rather than phosphatidylcholine, was the critical active element. Deoxycholic acid is thought to directly damage adipocyte cell membranes by inducing an inflammatory reaction.
Deoxycholic acid has been extensively studied for treating submental fat; numerous double-blind, multi-center, randomized clinical trials involving approximately 1800 patients found it safe and productive. In phase 3 trials, 1 mg/cm2 and 2 mg/cm2 were well-tolerated, safe, and more effective than placebo at reducing submental fat. Each subject received a maximum of four therapy sessions, with follow-up occurring 12 weeks after the previous session and the sessions spaced roughly 28 days apart. As effectiveness indicators, caliper measures, a subject self-rating scale (0-6), a clinician-reported submental fat rating scale, and a patient-reported submental fat rating scale were all employed.
Moderate to moderate pain, edema, ecchymosis, numbness, bleeding, induration, and fibrosis were all common side effects. 2.1% of deoxycholic acid patients developed transitory marginal mandibular nerve injury, resulting in an asymmetric grin. Test results and vital signs showed no clinically significant alterations. There were no documented deaths as a result of treatment. Deoxycholic acid 2 mg/cm2 had a patient satisfaction rating of 65.4% at the 12-week follow-up, compared to 60.8% for deoxycholic acid 1 mg/cm2 and 29.0% for placebo.
Deoxycholic acid and phosphatidylcholine (PC/DC) have been studied as injectable lipolytic agents. In addition, Lipostabil, a PC/DC combination, has been promoted extensively for many years.
What exactly is deoxycholic acid?
Your body naturally produces a substance known as deoxycholic acid, which aids in fat absorption. Deoxycholic acid, when administered into the body, destroys fat cells.
Deoxycholic acid can help lessen the appearance of fat hanging below the chin, sometimes known as a double chin. However, the safety of deoxycholic acid on other body regions has yet to be studied. Therefore, this pharmacological guide only covers some of the applications for deoxycholic acid.
How is deoxycholic acid administered?
Deoxycholic acid is injected beneath the skin just behind your chin. A healthcare expert will administer this injection to you. You may be offered a topical anesthetic or an ice pack for pain relief and comfort during the injections.
Deoxycholic acid must be delivered throughout six treatment sessions to succeed. Each session includes up to 50 injections. Each treatment session should be separated by at least one month. Many folks saw results after two to four sessions. Your doctor will determine the number of injections and sessions required based on your desired outcomes.
Detailed Description
Liposuction and cryolipolysis are current therapies for people with excess fat in their upper inner thighs (CoolSculpting, Allergan, Irvine, CA). In addition, the FDA-approved injectable deoxycholic acid (Kybella, Allergan, Irvine, CA) is administered to treat extra submental fat. However, deoxycholic acid may not be a safe and effective treatment for upper inner thigh fat. Therefore, the proposed clinical trial will investigate the safety and efficacy of deoxycholic acid in lowering upper inner thigh fat.
In this single-arm, open-label safety and efficacy trial, deoxycholic acid will be subcutaneously injected into 15 subjects with extra upper inner thigh fat throughout 1-4 treatment sessions. Subjects will be observed for 12 weeks after their definitive therapy. Adverse incidents will be recorded. After an independent review of before-and-after clinical photographs of the treatment area, effectiveness will be quantified by changes in thigh circumference, upper inner thigh skin fold thickness, increase in “thigh gap,” and percentage accuracy in correctly identifying baseline photographs by three blinded physicians. In addition, a Post-Treatment Satisfaction Questionnaire and a Subject Self-Rating Scale will be used to assess patient satisfaction with the research treatment.
Measurements of Results
- Key outcome indicators
Participants Who Had Adverse Events: Number [Period: from baseline to 12 weeks following final therapy]
- Any adverse event (AE) identified by patient reporting or medical assessment
- Serious adverse events (SAE), as defined by CTCAEv4, may include one or more adverse events that force the withdrawal of study medication.
- Change in Thigh Circumference [Period: from baseline to 12 weeks following final therapy] tape measure change in the diameter of the thighs
- Alteration in Upper Inner Thigh Skin Fold Thickness [Period: From baseline to 12 weeks after last treatment] Variation in body fat calipers-measured upper inner thigh skin fold thickness
Measurements of Results
- The primary outcome measures are the number of Individuals Experiencing Adverse Events [from baseline to 12 weeks after the last therapy].
- Any adverse event (AE) identified by patient reporting or medical assessment One or more serious adverse events (SAE) as defined by CTCAEv4 Adverse events leading to study drug cessation.
- Change in Thigh Circumference (From Baseline to Twelve Weeks Post-Last Treatment) – tape measure change in the diameter of the thighs.
- Change in Upper Inner Thigh Skin Fold Thickness (12 weeks following final treatment from baseline) – Use body fat calipers to assess the change in the thickness of the inner upper thigh skin fold.
- [12 weeks] Change in Thigh Gap – The “thigh gap” was defined as the horizontal distance between the baseline “sites of maximal bulging,” with feet at a standard distance apart, and was measured with a portable soft ruler.
- The proportion of blindfolded doctors accurately identifying before-and-after images [12 weeks] – The three blinded doctors correctly identified the before-and-after photos 83% of the time. Instead of accounting for individual participants, the percent accuracy for the entire Arm/Group was determined.
Result
The 14 individuals completed a total of 54 therapy sessions. 26.6 mL was the average dose volume. The three most prevalent local adverse events were edema (94.4%), bruising (90.7%), and erythema (79.6%), all of which were self-limiting (the mean duration was 9.6, 7, and 2 days, respectively). The length of erythema (p =.0421) was significantly linked with a DCA dose, but not the length of edema (p =.1611) or the incidence of bruising (p =.1013). Significant fat thickness reduction was observed during calipers, ultrasonography, and 3-dimensional scanning measurements. In addition, patient satisfaction levels improved significantly as measured by patient-reported outcome indicators.
Conclusion
Although deoxycholic acid should be reserved for modest deposits due to the cost/benefit ratio, it may be a safe and effective option for reducing fat thickness in the hypogastric area.
