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Evaluating the efficacy and safety of Deoxycholic acid injection (Embella®) in management of superficial lipomas

Protocol summary

Study aim
The purpose of this study is to evaluate the efficacy and safety of Deoxycholic Acid injection (brand name Embella) in the treatment of superficial lipoma
Design
Phase 4 clinical trial on 10 patients with lipoma, without control group
Settings and conduct
Injection of Deoxycholic Acid in the lipoma area with a total volume of 2 cc in each session up to a maximum of 3 sessions with monthly intervals is performed in the operating room of Razi Hospital. Before each injection, patients are evaluated by ultrasound and flexible meter. From the second session onwards, they also fill in the side effects questionnaire in all sessions. Participants are monitored for adverse effects each time, up to half an hour after the injection. If there were any adverse effects that require intervention study physicians are responsible 24 hours a day at Razi Hospital.
Participants/Inclusion and exclusion criteria
Patients aged 18-65 years with at least one superficial lipoma (proven clinically and based on ultrasound criteria) who have referred to Razi Hospital and are willing to undergo an intervention to treat lipoma are admitted. Lipoma should have characteristics such as a history of gradual growth, stability in the last 6 months, single and isolated, with an oval to circular shape, without a hard consistency or attachment to the underlying tissue, in the areas of the limbs and trunk and away from sensitive vascular-neural structures.
Intervention groups
Patients are injected with 0.1-0.15 cc of 10 mg/mL injectible Deoxycholic Acid solution (brand name Embella) per each 1 x 1 cm2 surface area of the lipoma, the maximum injection volume is 2 cc per session. Injections are done monthly up to 3 times.
Main outcome variables
percentage of lipoma size reduction; number of injection sessions; number of patients requiring surgical excision up to 4 months after the study; Incidence and severity of adverse events

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240416061507N2
Registration date: 2024-07-20, 1403/04/30
Registration timing: prospective

Last update: 2024-07-20, 1403/04/30
Update count: 0
Registration date
2024-07-20, 1403/04/30
Registrant information
Name
Navid Namakizadeh Esfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4409 6089
Email address
navidnamakizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-06, 1403/05/16
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the efficacy and safety of Deoxycholic acid injection (Embella®) in management of superficial lipomas
Public title
Evaluating the efficacy and safety of (Embella®) in management of superficial lipomas
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having at least one lipoma (clinically and sonographically proven) and accessible for diagnostic and therapeutic approaches with at least two vertical axes measurable and with the following conditions:The history of gradual growth, stability in the last 6 months, single and isolated, with an oval to circular shape, without a hard consistency or connection to the underlying tissue, in the areas of the limbs and trunk and away from sensitive vascular-neural structures Weight stability and body mass index less than 30 in the last 3 months Ability to complete the study and follow instructions Informed consent to participate in the study Consent not to undergo any other intervention for lipoma during the study period
Exclusion criteria:
Severe medical or psychological conditions that interfere with study results History of hypersensitivity to any of the components of the studied product Pregnancy and breastfeeding History of previous lipoma treatment BMI >۳۰ Patients prone to intravascular volume depletion Evidence of recent alcohol consumption or drug abuse History of bleeding disorders or recent intake (less than 3 weeks) of thrombolytic drugs, anticoagulants, platelet inhibitors, or NSAIDs History of hypertrophic scarring Infection, inflammation, dermatosis, non-healing wound, cancer or precancerous lesions at the lipoma site
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Central Building of Tehran University of Medical Sciences, Intersection of Qods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2024-04-20, 1403/02/01
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.010

Health conditions studied

1

Description of health condition studied
superficial lipoma
ICD-10 code
D17
ICD-10 code description
Benign lipomatous neoplasm

Primary outcomes

1

Description
Lipoma size reduction percentage
Timepoint
At the beginning of the study, before each injection session monthly up to 3 times, one month after the last injection
Method of measurement
Ultrasound

Secondary outcomes

empty

Intervention groups

1

Description
Only one intervention group: people aged 18-65 years with at least one superficial lipoma (clinically proven and based on ultrasound criteria) who have referred to Razi Hospital and are willing to undergo an intervention to treat lipoma are included. Before the intervention, patients are examined by a radiologist specialist and ultrasound is performed to check the nature of the mass and measure the size and volume of the lipoma and they will be included in the study in case of lipoma diagnosis and eligibility of other mentioned conditions. Then the patients are injected with 0.1-0.15 cc of 10 mg/mL injectable Deoxycholic Acid solution (brand name Embella, Espad Pharmed) for each area of ​​1 x 1 cm2 on the surface of the lipoma (injection depth is determined based on the ultrasound report in each case) and the maximum injection volume is 2 cc in each session. Drug injection is done monthly up to 3 times and before each injection lipoma dimensions are evaluated with ultrasound and flexible meter.Also, from the second session onwards, side effects questionnaire form is filled. If there are any side effects that require intervention of the project physicians at Razi Hospital, they will respond 24 hours a day. The injection of the mentioned drug in the lipoma area is done in the operating room of Razi Hospital, and the patients are observed for at least half an hour after the injection.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Kamran Balighi
Street address
Razi Hospital, Razi Dead End, Vahdat-Islami Square, Vahdat-Islami St., Tehran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Espad pharmed
Full name of responsible person
Nasim Anjidani
Street address
Third floor, Spad Farmed, No. 56, Azimi St., Nafisi St., Ekbatan, Tehran
City
Tehran
Province
Tehran
Postal code
1393933166
Phone
+98 21 4463 1124
Email
info@espadpharmedco.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Espad pharmed
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kamran Balighi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Razi Hospital,Razi Dead End,Vahdat-Islami Square,Tehran,Iran
City
Tehran
Province
Tehran
Postal code
1199663911
Phone
+98 21 5288 8282
Email
kamran.balighi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data on the main variable can be shared after de-identifying individuals
When the data will become available and for how long
Beginning of the access period up to one year after the publication of the results
To whom data/document is available
Researchers and industrialists based on the request and also the issuance of permission to access the data by the principal investigator and the sponsoring company of the project
Under which criteria data/document could be used
Use for review articles and use in the clinic
From where data/document is obtainable
Corresponding author kamran.balighi@yahoo.com
What processes are involved for a request to access data/document
Provide documentation of the reason for the request and follow-up via email after the permission to access the data is issued by the principal investigator and the sponsoring company of the project
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