Trial Condition(s):
Subcutaneous fat
Long-term follow-up study on safety and maintenance of efficacy of ATX-101
Bayer Identifier:
16045
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat
Inclusion Criteria
- 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 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
- Subjects 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)
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Praxis Fr. Dr. B. Gerlach Dresden, Germany, 01097 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Schleswig-Holstein / AÖR Lübeck, Germany, 23538 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Hr. Dr. G. Popp Augsburg, Germany, 86179 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Fr. Dr. med. Andrea Gräfe Northeim, Germany, 37154 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ästhetische Dermatologie Potsdam, Germany, 14467 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hautzentrum am Starnberger See GmbH Starnberg, Germany, 82319 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Ruhr-Universität Bochum St. Josef-Hospital Bochum, Germany, 44791 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charité Campus Virchow-Klinikum (CVK) Berlin, Germany, 13353 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ästhetische Dermatologie Münster, Germany, 48159 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Knappschafts-Krankenhaus Recklinghausen, Germany, 45657 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum der Johann Wolfgang Goethe Universität Frankfurt Frankfurt, Germany, 60596 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städt. KKH Dresden Friedrichstadt Dresden, Germany, 01067 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Darmstadt Darmstadt, Germany, 64276 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Praxis Dr. Walker & Dr. Biwer Ludwigshafen, Germany, 67061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CentroDerm Study Center Wuppertal, Germany, 42287 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gemeinschaftspraxis Mahlow Mahlow, Germany, 15831 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hautarztpraxis Cutanis Freiburg, Germany, 79117 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Long-term, follow-up study of subjects who completed phase 3 trials ATX-101-10-16 or ATX-101-10-17 (sodium deoxycholate injection) for the reduction of localized subcutaneous fat in the submental area
Trial Type:
Interventional
Intervention Type:
Procedure/Surgery
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
3
Primary Outcome
- Score on Clinician-reported submental fat rating scale (1-grade response)Maintenance of the treatment effectTimeframe: 24 months
- Score on Subject satisfaction rating scaleMaintenance of the treatment effectTimeframe: 24 months
Secondary Outcome
- Score on Clinician-reported submental fat rating scale (2-grade response)Timeframe: 24 months
- Score on Patient-reported submental fat impact scale (1-grade response)Timeframe: 24 months
- Score on Composite submental fat rating scale (1-grade response)Improvement observed both in clinician-reported submental fat rating scale and patient-reported submental fat rating scaleTimeframe: 24 months
- Number and percentage of subjects with treatment-emergent adverse eventsTimeframe: Up to 24 months
- Number and percentage of subjects with treatment-emergent adverse events associated with the treatment area (drug related)Timeframe: Up to 24 months
- Number and percentage of subjects with treatment-emergent adverse events of special interestTimeframe: Up to 24 months
Additional Information
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