Study to evaluate the safety and efficacy of Belkyra™ in the fat located in the hypogastric zone.

Phase 1

• Conditions: Subjects with fat located in the treatment area (hypogastrium); Therapeutic area: Not possible to specify

• Registration Number: EUCTR2018-001659-11-ES
• Lead Sponsor: COSMETIC SURGERY BCN SLP

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-09
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

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

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified