Controlled Study of the Effect of Xenaderm® Ointment Vehicle Versus White Petrolatum on Healing

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Healthpoint
ClinicalTrials.gov Identifier:
NCT00713349
First received: July 9, 2008
Last updated: October 9, 2013
Last verified: October 2013
Results First Received: October 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Investigator);   Primary Purpose: Treatment
Condition: Wounds
Interventions: Drug: Xenaderm Vehicle
Other: Placebo comparator

  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
Healthy adult volunteers, 18 years of age and older

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Each subject acting as their own control

Reporting Groups
  Description
Vehicle vs. Placebo

Xenaderm Vehicle and White Petrolatum as Placebo Comparator

Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.

White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days

Each subject acting as their own control


Participant Flow:   Overall Study
    Vehicle vs. Placebo  
STARTED     25  
COMPLETED     24  
NOT COMPLETED     1  
Protocol Violation                 1  



  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
Vehicle vs. Placebo

Xenaderm Vehicle and White Petrolatum as Placebo Comparator

Xenaderm Vehicle : Ointment to be applied three times a day on cryo-surgery wound for 21 days.

White Petrolatum : Ointment to be applied three times a day on cryo-surgery wound for 21 days

Each subject acting as their own control


Baseline Measures
    Vehicle vs. Placebo  
Number of Participants  
[units: participants]
  25  
Age  
[units: participants]
 
<=18 years     1  
Between 18 and 65 years     24  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  43  ± 12.1  
Gender  
[units: participants]
 
Female     22  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     25  



  Outcome Measures

1.  Primary:   Complete Wound Closure   [ Time Frame: 21 Days ]


  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
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Jaime Dickerson, PhD
Organization: Smith & Nephew Biotherapeutics
phone: 817-302-3914
e-mail: jaime.dickerson@smith-nephew.com


No publications provided


Responsible Party: Healthpoint
ClinicalTrials.gov Identifier: NCT00713349     History of Changes
Obsolete Identifiers: NCT00693810
Other Study ID Numbers: 011-101-09-004
Study First Received: July 9, 2008
Results First Received: October 9, 2013
Last Updated: October 9, 2013
Health Authority: United States: Food and Drug Administration