check_circleStudy Completed

Subcutaneous fat

Bayer Identifier:

16045

ClinicalTrials.gov Identifier:

NCT02052622

EudraCT Number:

2011-005026-21

EU CT Number:

Not Available
Long-term follow-up study on safety and maintenance of efficacy of ATX-101

Trial purpose

To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - 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
  • - 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
February 2012 - December 2013
Phase
Phase 3
Could I Receive a placebo
No
Products
Deoxycholic Acid (BAY1142531)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Praxis Fr. Dr. B. GerlachDresden, 01097, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Praxis Hr. Dr. G. PoppAugsburg, 86179, Germany
Completed
Praxis Fr. Dr. med. Andrea GräfeNortheim, 37154, Germany
Completed
Ästhetische DermatologiePotsdam, 14467, Germany
Completed
Hautzentrum am Starnberger See GmbHStarnberg, 82319, Germany
Completed
Klinikum der Ruhr-Universität Bochum St. Josef-HospitalBochum, 44791, Germany
Completed
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 80336, Germany
Completed
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Completed
Ästhetische DermatologieMünster, 48159, Germany
Completed
Knappschafts-KrankenhausRecklinghausen, 45657, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60596, Germany
Completed
Städt. KKH Dresden FriedrichstadtDresden, 01067, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60596, Germany
Completed
Klinikum DarmstadtDarmstadt, 64276, Germany
Completed
Praxis Dr. Walker & Dr. BiwerLudwigshafen, 67061, Germany
Completed
CentroDerm Study CenterWuppertal, 42287, Germany
Completed
Gemeinschaftspraxis MahlowMahlow, 15831, Germany
Completed
Hautarztpraxis CutanisFreiburg, 79117, Germany

Primary Outcome

  • Score on Clinician-reported submental fat rating scale (1-grade response)
    Maintenance of the treatment effect
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Score on Subject satisfaction rating scale
    Maintenance of the treatment effect
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Score on Clinician-reported submental fat rating scale (2-grade response)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Score on Patient-reported submental fat impact scale (1-grade response)
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • 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 scale
    date_rangeTime Frame:
    24 months
    enhanced_encryption
    Safety Issue:
    No
  • Number and percentage of subjects with treatment-emergent adverse events
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number and percentage of subjects with treatment-emergent adverse events associated with the treatment area (drug related)
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes
  • Number and percentage of subjects with treatment-emergent adverse events of special interest
    date_rangeTime Frame:
    Up to 24 months
    enhanced_encryption
    Safety Issue:
    Yes

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

Additional Information

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