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A Dose Escalation Study Using Collagenase Clostridium Histolyticum in the Treatment of Lipoma

This study has been completed.
Sponsor:
Collaborator:
Advance Biofactures Corporation
Information provided by (Responsible Party):
Zachary Gerut, Gerut, Zachary, M.D.
ClinicalTrials.gov Identifier:
NCT01613313
First received: June 5, 2012
Last updated: February 10, 2016
Last verified: February 2016
Results First Received: February 10, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Lipoma
Intervention: Drug: Collagenase Clostridium Histolyticum

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened and enrolled at 1 site in the United States

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dose #1

single injection 0.058 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #2

single injection 0.15 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #3

single injection 0.29 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #4

single injection 0.44 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.


Participant Flow:   Overall Study
    Dose #1     Dose #2     Dose #3     Dose #4  
STARTED     2     4     4     4  
COMPLETED     2     4     4     4  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Dose #1

single injection 0.058 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #2

single injection 0.15 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #3

single injection 0.29 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Dose #4

single injection 0.44 mg Collagenase Clostridium Histolyticum

Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Total Total of all reporting groups

Baseline Measures
    Dose #1     Dose #2     Dose #3     Dose #4     Total  
Number of Participants  
[units: participants]
  2     4     4     4     14  
Age  
[units: Years]
Mean (Standard Deviation)
  48.0  (5.66)     51.5  (12.50)     41.3  (11.09)     57.0  (4.97)     49.6  (10.60)  
Gender  
[units: participants]
         
Female     2     3     3     1     9  
Male     0     1     1     3     5  
Region of Enrollment  
[units: participants]
         
United States     2     4     4     4     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduction in Visible Surface Area of the Lipoma   [ Time Frame: Six months post injection of study drug ]

2.  Secondary:   Relative Change in Volume of the Lipoma   [ Time Frame: 6 months post injection of study drug ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Dr. Zachary E.Gerut
Organization: GerutZ
phone: 516 295-2100
e-mail: Drgerut@drgerut.com



Responsible Party: Zachary Gerut, Gerut, Zachary, M.D.
ClinicalTrials.gov Identifier: NCT01613313     History of Changes
Other Study ID Numbers: Lipoma DE/01
Study First Received: June 5, 2012
Results First Received: February 10, 2016
Last Updated: February 10, 2016
Health Authority: United States: Food and Drug Administration