Flank Fat
Conditions
Brief summary
Flank region fat is a factor affecting beauty that makes people feel uncomfortable about themselves. In 2015, deoxycholic acid was approved by the American FDA for treatment of flank fat. The purpose of this study is to evaluate the efficacy and safety of deoxycholic acid injection with the brand name Embella®, manufactured by Espad Pharmed Company, for treatment of this condition. The Primary objective of this study was the proportion of participants with grade 1 or higher ("improved, much improved, very much improved") in investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12 Secondary objective was assessment of other efficacy parameters as well as safety of the product
Interventions
The intervention include Deoxycholic acid, SC, 0.15 ml each injection, up to 2-4 ml in each site (2 ml at visit 1 for everyone, and 2 ml at visit 2 unless the patient does not agree)
Sponsors
Espad Pharmed
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
before/after clinical trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 12 | Week 12 | A comparison between Week 12 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse). The average score between the investigators was taken. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Right and Left Thigh Circumference at Weeks 6 and 12 Using a Flexible Tape Measure | Baseline, Week 6, Week 12 | — |
| Changes From Baseline in Caliper Measurement (mm) of Flank Fat on Each Side at Weeks 6 and 12 | Baseline, Week 6, Week 12 | — |
| Changes From Baseline in Waist Circumference at Weeks 6 and 12 Using a Flexible Tape Measure | Baseline, Week 6, Week 12 | — |
| Safety Assessment by Evaluation of Adverse Events (AEs) | Up to week 12 | Number of participants with at least one adverse event (AE). AEs were assessed at all visits. |
| The Proportion of Participants With Grade 1 or Higher ("Improved, Much Improved, Very Much Improved") in Investigator-assessed Global Aesthetic Improvement Scale (GAIS) at Week 6 | Week 6 | A comparison between Week 6 and Baseline standardized photographs will be made by two independent physicians, resulting in a GAIS score from the range +3 (very much improved), +2 (much improved), +1 (improved), 0 (no change), -1 (worse), -2 (much worse), and -3 (very much worse). The average score between the investigators was taken. |
| Change From Baseline in Ultrasonographic Measurement of Dermal and Hypodermal Thickness on Both Flanks at Weeks 6 and 12 | Baseline, Week 6, Week 12 | — |
| Changes From Baseline in the Bodyweight (Kg) at Weeks 6 and 12 | Baseline, Week 6, Week 12 | — |
| Subject's Satisfaction at Weeks 6 and 12 Using a 10-point Likert Scale | Week 6, Week 12 | A 10-point Likert scale is used to measure subject's satisfaction, comprising a question followed by a scale with ten choices, going from "1" (Completely dissatisfied) to "10" (Completely satisfied). |
Countries
Iran
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.93 years STANDARD_DEVIATION 4.83 |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 30 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
None listed