Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
- Conditions
- Reduction of subcutaneous fat in the submental areaMedDRA version: 9.1 Level: LLT Classification code 10016251 Term: Fat tissue increased
- Registration Number
- EUCTR2007-006303-21-GB
- Lead Sponsor
- Kythera Biopharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- Not specified
- Target Recruitment
- 60
1. Submental fat that is considered undesirable by the participant and graded by the Investigator as 2 or 3 using the SMF Rating Scale (Appendix C of the protocol).
2. Males or nonpregnant, nonlactating females who are aged 25 to 65 years, inclusive, on the date of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (HCG) test result within 28 days before randomization and must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial.
3. History of maintenance of a stable body weight, in the judgement of the Investigator, for at least 6 months before randomization.
4. The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures.
5. The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations (section 7 of the protocol) obtained within 28 days before randomization, for which the investigator identifies no clinically significant abnormality.
6. Signed informed consent obtained before any study specific procedure is conducted.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. History of any intervention to treat submental fat (e.g. liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect safety or efficacy evaluation of the treatment.
2. Loose skin in the neck or chin area for which reduction in submental fat may, in the judgement of the Investigator, result in a cosmetically unacceptable outcome.
3. Prominent platysmal bands at rest that interfere with the evaluation of submental fat.
4. Evidence of any cause of enlargement in the submental area (eg. thyroid enlargement, cervical adenopathy) other than localised submental fat.
5. Fitzpatrick Skin Type IV, V, or VI (Appendix B of the protocol).
6. Currently on, or considering starting, a weight reduction regimen.
7. Any medical condition (e.g. respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interefere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent.
8. Treatment with fish oil or nonsteroidal anti-inflammatory agents (NSAIDs) within seven days before randomisation, or any anticipated need for agents with anticoagulative effects (e.g. warfarin, heparin) during the course of the trial. Aspirin used for prophylaxis will be allowed.
9. Treatment with oral anticoagulants (e.g. warfarin) within 28 days before randomisation.
10. Treatment with radio frequency, laser procedures, chemical peel, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections within 6 months before randomization.
11. History of sensitivity to any components of the study material or to topical or local anaesthetics (e.g. lidocaine, benzocaine, novocaine).
12. Previous randomization into this trial.
13. Treatment with an investigational device or agent within 30 days before randomization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the safety and tolerability of ATX-101 injections at one concentration and three dosing paradigms, relative to placebo.;Secondary Objective: To evaluate the potential efficacy of ATX-101, relative to placebo, in reducing subcutaneous fat in the submental area.;<br> Primary end point(s): Safety endpoints include:<br> - incidence, severity, and duration of all treatment-emergent adverse events<br> - incidence of study material-related adverse events<br> - severity and duration of study material-related adverse events<br> - changes from baseline in clinical laboratory and urinalysis test results<br> - changes from baseline in vital sign and weight measurements<br><br> Efficacy endpoints include change from baseline in the SMF (submental fat) rating scale, the Subject Satisfaction with Appearance rating scale, and the Subject Global Improvement rating obtained at visit 10.<br>
- Secondary Outcome Measures
Name Time Method