Subjects with fat located in the treatment area (hypogastrium)
Conditions
Interventions
Trade Name: Belkyra 10 mg/ml solución inyectable
Product Name: BELKYRA
Pharmaceutical Form: Solution for injection
Sponsors
COSMETIC SURGERY BCN SLP
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects with fat located in the treatment area (hypogastrium). 2. Subjects with dissatisfaction with fat located in that area (hypogastrium). 3. Males or non-pregnant or non-breastfeeding females from 25 to 50 years. 4. Stable body weight in the last 6 months, with no intention of making changes in diet or sport in the next months. 5. BMI between 18 and 25 kg/cm2. 6. Expected to comply with and understand the visit schedule and the protocol tests. 7. Subject without any serious disease that could interfere the administration of the product. 8. Subjects willing to sign the informed consent form for the study’s participation before first dose is administered. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of any intervention to treat hypogastric fat (eg, liposuction, surgery or lipolytic agents). 2. Subjects with known coagulation disorders or that are being treated with anticoagulation therapy. 3. Any medical condition (eg, respiratory, cardiovascular, hepatic, neurological disease or thyroid dysfunction) that could interfere with assessment of safety or efficacy or compromise the subject’s ability to perform study procedures or give informed consent. 4. History of sensitivity or allergy to any component/excipient of the study drug. 5. Subjects participating in other clinical trials in the last 3 months. 6. Fertile women of childbearing potential (WCBP) not willing to use double barrier methods of contraception (abstinence, oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly, or surgically sterile) during the trial and 90 days after the end of treatment. Male patients whose partners are not willing to use double-barrier methods of contraception.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety: Evaluate the safety of transcutaneous, intra-adipose injections of Belkyra™ in the hypogastric area, assessed by adverse event reports and clinical evaluation of the treated area (Hypogastrium).; Secondary Objective: - To evaluate the efficacy of Belkyra™ using 0.2 ml/cm2 for reduction of the localized fat of the hypogastrium, based on caliper, ultrasound and 3D camera. - Patient Related Outcomes measures (PROM), obtained by a satisfaction scale. - Relationship between dosage and reduction of thickness measured by ultrasound and 3D camera. ; Primary end point(s): The primary endpoint is the safety of transcutaneous, intra-adipose injections of Belkyra™ in the hypogastric area, evaluated by adverse events and clinical evaluation of treated area. The adverse events reported by subjects in each visit will be collected in the medical history and in the CRF. In addition, in each visit, investigator will evaluate the treated area (hypogastrium) in order to find out if subject shows any of the following characteristics: edema, bruising, erythema, hyperpigmentation, hypopigmentation, induration, numbness, pain, paresthesias, disesthesias, irregularities (dimples). ; Timepoint(s) of evaluation of this end point: None subject will receive more than 4 treatment sessions, no more than 0.2 ml for any individual injection and no more than 10 ml per area (half abdomen) accounting for 20 ml in total. Study will last maximum 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the efficacy of Belkyra in the reduction of localized fat of the hypogastrium (reduction in mm of the circumference of the treated zone) evaluated by caliper, ultrasound and 3D camera. - To measure the subject satisfaction using the Patient Reported Outcomes Measure scale (PROM) (Scale from 0 to 4, being 0: very dissatisfied: 1: somewhat dissatisfied; 2: neutral; 3: somewhat satisfied; 4: very satisfied). - To measure the relationship between dosage and reduction of thickness evaluated by ultrasound and 3D camera. ;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Countries
Spain
Contacts
Public ContactJesús Benito
COSMETIC SURGERY BCN SLP
Outcome results
None listed