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:

NCT02052622

EudraCT Number:

2011-005026-21

Study Completed

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
201
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Deoxycholic Acid (BAY1142531)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Praxis Fr. Dr. B. Gerlach

Dresden, Germany, 01097

Status
Completed
 
Locations

Universitätsklinikum Schleswig-Holstein / AÖR

Lübeck, Germany, 23538

Status
Completed
 
Locations

Praxis Hr. Dr. G. Popp

Augsburg, Germany, 86179

Status
Completed
 
Locations

Praxis Fr. Dr. med. Andrea Gräfe

Northeim, Germany, 37154

Status
Completed
 
Locations

Ästhetische Dermatologie

Potsdam, Germany, 14467

Status
Completed
 
Locations

Hautzentrum am Starnberger See GmbH

Starnberg, Germany, 82319

Status
Completed
 
Locations

Klinikum der Ruhr-Universität Bochum St. Josef-Hospital

Bochum, Germany, 44791

Status
Completed
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Completed
 
Locations

Charité Campus Virchow-Klinikum (CVK)

Berlin, Germany, 13353

Status
Completed
 
Locations

Ästhetische Dermatologie

Münster, Germany, 48159

Status
Completed
 
Locations

Knappschafts-Krankenhaus

Recklinghausen, Germany, 45657

Status
Completed
 
Locations

Klinikum der Johann Wolfgang Goethe Universität Frankfurt

Frankfurt, Germany, 60596

Status
Completed
 
Locations

Städt. KKH Dresden Friedrichstadt

Dresden, Germany, 01067

Status
Completed
 
Locations

Klinikum Darmstadt

Darmstadt, Germany, 64276

Status
Completed
 
Locations

Praxis Dr. Walker & Dr. Biwer

Ludwigshafen, Germany, 67061

Status
Completed
 
Locations

CentroDerm Study Center

Wuppertal, Germany, 42287

Status
Completed
 
Locations

Gemeinschaftspraxis Mahlow

Mahlow, Germany, 15831

Status
Completed
 
Locations

Hautarztpraxis Cutanis

Freiburg, Germany, 79117

Status
Completed
 

Trial Design