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Tests treatment safety and results for Lipoma
Official title Evaluating the Efficacy and Safety of Embella (Deoxycholic Acid, Produced by Espad Pharmed Co.) Injection in the Management of Superficial Lipomas
ClinicalTrials.gov ID: NCT07014163
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Men and women aging between 18 to 65 years
- Having at least one lipoma (based on clinical and sonographic diagnosis), which is accessible for treatment and assessment and is quantifiable along...
- History of slow growth followed by dormancy
- Being stable for at least 6 months
- Greatest length by greatest perpendicular width between 4 and 4 square centimeters
You likely can't join if
- Any medical and physical conditions (for example, high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders)...
- 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 study
- 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...
- Previous treatment for lipomas
- people planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation
See the full eligibility criteria
- Men and women aging between 18 to 65 years
- Having at least one lipoma (based on clinical and sonographic diagnosis), which is accessible for treatment and assessment and is quantifiable along at least 2 perpendicular diameters and lower than 2 centimeter in...
- History of slow growth followed by dormancy
- Being stable for at least 6 months
- Greatest length by greatest perpendicular width between 4 and 4 square centimeters
- Inclusive discrete, oval to rounded in shape, not hard or attached to underlying tissue
- Located on the trunk, upper and lower limbs, far from main and vulnerable neurovascular structures
- Stable body weight with a body mass index of less than 30 kg/m² in the past three months
- Signed informed consent
- Ability to follow study instructions and likely to complete all required visits
- Agreement to abstain from any treatment for lipomas during the study
- Any medical and physical conditions (for example, high blood pressure or respiratory, cardiovascular, liver, neurological, or thyroid disorders) that, in the opinion of the attending physician, affect the evaluation of...
- 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 study
- 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 for lipomas
- people planning a surgical procedure for lipoma during the study or at any time that may affect the evaluation
- people 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...
- 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 a tendency 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 an active inflammation, dermatoses, infection, cancerous or precancerous lesion, or unhealed wound in the site of lipoma
- 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 team makes the final eligibility decision.
Where it's taking place
- Tehran, Tehran Province, Iran
- Tehran, Iran
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tehran, Tehran Province, Iran; Tehran, Iran. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.