A Phase 2 Study of ATX 101 (Sodium Deoxycholate for injection) Given by Three Dosing Paradigms for the Reduction of Submental Fat (Double Chin).
- Conditions
- Submental FatSkin - Other skin conditions
- Registration Number
- ACTRN12607000626460
- Lead Sponsor
- Kythera Biopharmaceuticals Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1.Submental fat that is considered undesirable by the subject and graded by the investigator as 2 or 3 using the Submental Fat (SMF) Rating Scale (Appendix C).
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 judgment 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) 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..
Exclusion Criteria
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 judgment 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 (e.g., thyroid enlargement, cervical adenopathy) other than localized submental fat.
5.Fitzpatrick Skin Type IV, V, or VI (Appendix B).
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 interfere 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 randomization, 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 randomization.
10.Treatment with radio frequency, laser procedures, chemical peel, 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 anesthetics (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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the safety and tolerability of ATX-101 injections at one concentration and three dosing paradigms, relative to placebo.[Subjects will undergo protocol defined tests and observations at screening, four treatment visits (Visits 2, 4, 6, and 8 [+- 3 days]), four postinjection visits each one week (+- 2 days) after treatment, safety assessments at each visit, and efficacy assessments at Visits 4, 6, 8, 10, and 12. Each subject's participation in the trial will be terminated at the conclusion of all tests and observations conducted at Visit 12 (12 weeks after the final dose of study material).]
- Secondary Outcome Measures
Name Time Method To evaluate the potential efficacy of ATX-101, relative to placebo, in reducing SMF[Subjects will undergo protocol defined tests and observations at screening, four treatment visits (Visits 2, 4, 6, and 8 [+- 3 days]), four postinjection visits each one week (+- 2 days) after treatment, safety assessments at each visit, and efficacy assessments at Visits 4, 6, 8, 10, and 12. Each subject's participation in the trial will be terminated at the conclusion of all tests and observations conducted at Visit 12 (12 weeks after the final dose of study material).]