Long-term 24-month Follow-up Study on Safety and Maintenance of Efficacy of ATX-101 (Sodium Deoxycholate Injection)

Study Identifier
1403740
CT.gov Identifier
NCT03682471
EudraCT Identifier
2011-005026-21
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Study Details

Medical Condition
  • Other
    • Study Drug
  • Deoxycholic acid Injection
  • Placebo
    • Phase
    N/A
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Signed written informed consent before any study-related activities are carried out * Any participant who successfully completed the final visit (visit 7) of a phase 3 clinical trial, ATX-101-10-16 or ATX-101-10-17 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
    Exclusion Criteria:
    * Participants who, since the completion of the prior phase 3 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)

    Protocol Summary

    The objective of this non-treatment, placebo-controlled, observational, 24-month follow-up study was to evaluate the long-term efficacy and safety of subcutaneous (SC) injections of deoxycholic acid (ATX-101) in the submental area. No treatment was administered in this study. Participants who previously received deoxycholic acid injections in studies ATX-101-10-16 \[NCT01305577\] or ATX-101-10-17 \[NCT01294644\] were enrolled in this non-treatment observational follow-up study to further evaluate safety and efficacy.

    Study Locations

    Location
    Status
    Location
    Licca Clinical Research Institute
    Augsburg, Germany, 86179
    Status
    Not applicable
    Location
    Campus Charité Mitte, Klinik für Dermatologie, Venerologie und Allergologie
    Berlin, Germany, 10117
    Status
    Not applicable
    Location
    Ruhruniversität Bochum - St. Josef Hospital
    Bochum, Germany, 44791
    Status
    Not applicable
    Location
    Klinikum Darmstadt
    Darmstadt, Germany, 64297
    Status
    Not applicable
    Location
    Krankenhaus Dresden- Friedrichstadt Klinik für Dermatologie und Allergologie
    Dresden, Germany, 01067
    Status
    Not applicable
    Location
    Dr. Beatrice Gerlach
    Dresden, Germany, 01097
    Status
    Not applicable
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