ong-term, follow-up study of subjects who completed phase III trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area - Long-term follow-up study of ATX-101 for reduction of localized submental fat
- Conditions
- Reduction of subcutaneous fat in the submental areaMedDRA version: 17.1Level: PTClassification code 10016251Term: Fat tissue increasedSystem Organ Class: 10018065 - General disorders and administration site conditionsTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2011-005026-21-DE
- Lead Sponsor
- KYTHERA Biopharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 201
- Signed written informed consent before any study-related activities are carried out
- Any subject who successfully completed the final visit (Visit 7) of a phase III clinical trial, ATX-101-16 or ATX-101-17 for the reduction of submental fat, i.e. subjects must have at least one study treatment administered and have completed the predecessor study up to Visit 7
- Willingness to comply with the schedule and procedures of the study
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Subjects who, since the completion of the prior phase III study ATX-101-10-16 or ATX-101-10-17, have had or who are undergoing treatment that may affect the evaluation of the submental area (e.g. - but not limited to - long term treatment with systemic corticosteroids, liposuction, surgery or other lipolytic treatment in the submental area, treatment with radio frequency, laser procedures, chemical peels, dermal fillers in the neck or chin area or botulinum toxin injections in the neck or chin area).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term efficacy and safety of transcutaneous injections of ATX-101 in the submental area;Secondary Objective: ;Primary end point(s): To evaluate the long-term efficacy and safety of transcutaneous injections of ATX-101 in the submental area; primary variable is not applicable
- Secondary Outcome Measures
Name Time Method